{"fetched":"2026-11-09","classification":{"lastUpdated":"2026-10-26","total":7097},"recalls":{"lastUpdated":"2026-11-05","records":59323},"regulations":{"asOf":"2026-11-05"},"panels":{"AN":"Anesthesiology","CV":"Cardiovascular","CH":"Clinical Chemistry","DE":"Dental","EN":"Ear, Nose, Throat","GU":"Gastroenterology, Urology","HO":"General Hospital","HE":"Hematology","IM":"Immunology","MG":"Medical Genetics","MI":"Microbiology","NE":"Neurology","OB":"Obstetrics/Gynecology","OP":"Ophthalmic","OR":"Orthopedic","PA":"Pathology","PM":"Physical Medicine","RA":"Radiology","SU":"General, Plastic Surgery","TX":"Clinical Toxicology"},"exemptions":["Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning complaint files under § 820.35(a) of this chapter.","The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The device is also exempt from the good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. The device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820, except for requirements concerning records and complaint files under § 820.35 of this chapter.","The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter."],"codes":[{"c":"BRT","n":"Restraint, Patient, Conductive","k":"1","r":"880.6760","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0},{"c":"BRW","n":"Protector, Dental","k":"1","r":"868.5820","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":0},{"c":"BRX","n":"Stool, Anesthesia","k":"1","r":"868.6700","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":1},{"c":"BRY","n":"Cabinet, Table And Tray, Anesthesia","k":"1","r":"868.6100","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":5,"b":0,"e":99},{"c":"BRZ","n":"Set, Blood Transfusion","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":30,"b":0,"e":24},{"c":"BSA","n":"Warmer, Blood, Electromagnetic Radiation","k":"3","r":"864.9205","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0},{"c":"BSB","n":"Warmer, Blood, Non-Electromagnetic Radiation","k":"2","r":"864.9205","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":14,"b":0,"e":2},{"c":"BSD","n":"Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling","k":"3","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0},{"c":"BSE","n":"Analyzer, Gas, Helium, Gaseous-Phase","k":"2","r":"868.1640","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0},{"c":"BSF","n":"Absorber, Carbon-Dioxide","k":"1","r":"868.5310","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":8,"b":0,"e":6},{"c":"BSI","n":"Algesimeter, Powered","k":"2","r":"868.1040","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0},{"c":"BSJ","n":"Mask, Gas, Anesthetic","k":"1","r":"868.5550","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":51,"b":0,"e":1},{"c":"BSK","n":"Cuff, Tracheal Tube, Inflatable","k":"2","r":"868.5750","p":"AN","g":"N","l":"Y","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":40,"b":0,"e":4},{"c":"BSN","n":"Filter, Conduction, Anesthetic","k":"2","r":"868.5130","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":1},{"c":"BSO","n":"Catheter, Conduction, Anesthetic","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":75,"b":0,"e":119},{"c":"BSP","n":"Needle, Conduction, Anesthetic (W/Wo Introducer)","k":"2","r":"868.5150","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":152,"b":0,"e":17},{"c":"BSR","n":"Stylet, Tracheal Tube","k":"1","r":"868.5790","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":32,"b":0,"e":16},{"c":"BSS","n":"Tube, Nasogastric","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":5},{"c":"BST","n":"Curette, Biopsy, Bronchoscope (Non-Rigid)","k":"2","r":"874.4680","p":"EN","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"BSY","n":"Catheters, Suction, Tracheobronchial","k":"1","r":"868.6810","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":116,"b":0,"e":89},{"c":"BSZ","n":"Gas-Machine, Anesthesia","k":"2","r":"868.5160","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":189,"b":0,"e":177},{"c":"BTA","n":"Pump, Portable, Aspiration (Manual Or Powered)","k":"2","r":"878.4780","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":160,"b":0,"e":21},{"c":"BTB","n":"Hook, Ether","k":"1","r":"868.5420","p":"AN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"x":11},{"c":"BTC","n":"Bag, Reservoir","k":"1","r":"868.5320","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":19,"b":0,"e":7},{"c":"BTG","n":"Brush, Biopsy, Bronchoscope (Non-Rigid)","k":"2","r":"874.4680","p":"EN","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":2,"d":"If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"BTI","n":"Compressor, Air, Portable","k":"2","r":"868.6250","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":74,"b":0,"e":5},{"c":"BTK","n":"Strap, Head, Gas Mask","k":"1","r":"868.5560","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":6,"b":0,"e":0},{"c":"BTL","n":"Ventilator, Emergency, Powered (Resuscitator)","k":"2","r":"868.5925","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":100,"b":0,"e":29},{"c":"BTM","n":"Ventilator, Emergency, Manual (Resuscitator)","k":"2","r":"868.5915","p":"AN","g":"N","l":"Y","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":210,"b":0,"e":97},{"c":"BTO","n":"Tube, Tracheostomy (W/Wo Connector)","k":"2","r":"868.5800","p":"AN","g":"N","l":"Y","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":129,"b":0,"e":73},{"c":"BTP","n":"Dropper, Ether","k":"1","r":"868.5420","p":"AN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"x":11},{"c":"BTQ","n":"Airway, Nasopharyngeal","k":"1","r":"868.5100","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":19,"b":0,"e":2},{"c":"BTR","n":"Tube, Tracheal (W/Wo Connector)","k":"2","r":"868.5730","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":242,"b":0,"e":227},{"c":"BTS","n":"Tube, Bronchial (W/Wo Connector)","k":"2","r":"868.5720","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":11},{"c":"BTT","n":"Humidifier, Respiratory Gas, (Direct Patient Interface)","k":"2","r":"868.5450","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":222,"b":0,"e":70},{"c":"BTX","n":"Board, Arm (With Cover), Sterile","k":"1","r":"878.3910","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":13,"b":0,"e":0},{"c":"BTY","n":"Calculator, Predicted Values, Pulmonary Function","k":"2","r":"868.1890","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":64,"b":0,"e":4},{"c":"BWA","n":"Unit, Electrosurgical And Coagulation, With Accessories","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0},{"c":"BWB","n":"Forceps, Tube Introduction","k":"1","r":"868.5780","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":6,"b":0,"e":1},{"c":"BWC","n":"Needle, Emergency Airway","k":"2","r":"868.5090","p":"AN","g":"N","l":"Y","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":14,"b":0,"e":2},{"c":"BWF","n":"Spirometer, Therapeutic (Incentive)","k":"2","r":"868.5690","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":108,"b":0,"e":1},{"c":"BWH","n":"Forceps, 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Counter","k":"2","r":"862.3610","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1},{"c":"NGI","n":"Test, Morphine, Over The Counter","k":"2","r":"862.3640","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0},{"c":"NGJ","n":"Test, Nitrite, Urinary, Non-Quantitative, Over The Counter","k":"1","r":"862.1510","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1},{"c":"NGK","n":"Test, Occult Blood, Over The Counter","k":"2","r":"864.6550","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0},{"c":"NGL","n":"Test, Opiates, Over The Counter","k":"2","r":"862.3650","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":23,"b":0,"e":0},{"c":"NGM","n":"Test, Phencyclidine (Pcp), Over The Counter","k":"U","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":0,"b":0,"e":0,"d":"The phencyclidine test is an in vitro diagnostic test for the qualitative analysis of phencyclidine in human urine."},{"c":"NGO","n":"Test, Triglycerides, Over The Counter","k":"1","r":"862.1705","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0},{"c":"NGR","n":"Tester, Stiffness, Cartilage, Arthroscopic","k":"2","r":"888.1100","p":"OR","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0},{"c":"NGS","n":"Assay, Endotoxin Activity, Chemiluminescent","k":"2","r":"866.3210","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0},{"c":"NGT","n":"Saline, Vascular Access Flush","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":40,"b":0,"e":61,"d":"Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use."},{"c":"NGU","n":"Balloon, Liver Tamponade","k":"2","r":"876.5980","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0},{"c":"NGV","n":"System, Appendage Closure, Left Atrial","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":4},{"c":"NGX","n":"Stimulator, Muscle, Powered, For Muscle Conditioning","k":"2","r":"890.5850","p":"PM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":163,"b":0,"e":3,"d":"A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes."},{"c":"NGY","n":"Cannula, Trocar, Ophthalmic","k":"1","r":"886.4350","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":11,"d":"The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures."},{"c":"NGZ","n":"Susceptibility Test Plate, Antifungal","k":"2","r":"866.1640","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":21,"b":0,"e":5,"d":"The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format."},{"c":"NHA","n":"Abutment, Implant, Dental, Endosseous","k":"2","r":"872.3630","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":716,"b":0,"e":225,"d":"To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation."},{"c":"NHB","n":"Polymer, Ear, Nose And Throat, Synthetic, Absorbable","k":"2","r":"874.3620","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":16,"b":0,"e":15,"d":"Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials."},{"c":"NHC","n":"Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)","k":"2","r":"882.4100","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain."},{"c":"NHF","n":"Monitor, Orthotic/Prosthetic","k":"1","r":"890.3025","p":"PM","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A monitor, orthotic/prosthetic is a non-invasive, battery-powered, data storage accessory device that is attached to or embedded in medical appliances such as splints, braces, orthotics, prosthetics, and wearable exercise devices, to record how often the appliance is worn, through the use of sensors that record changes in temperature, motion, skin proximity, etc.","x":36},{"c":"NHG","n":"Enzyme Immunoassay, Cortisol, Salivary","k":"2","r":"862.1205","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":5,"d":"The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples."},{"c":"NHH","n":"Device, Discharge, Electrostatic (For Pain Relief)","k":"2","r":"890.5500","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain"},{"c":"NHI","n":"Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":0,"d":"Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,"},{"c":"NHJ","n":"Device, Positive Pressure Breathing, Intermittent","k":"2","r":"868.5905","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":26,"b":0,"e":17},{"c":"NHK","n":"Resuscitator, Manual, Non Self-Inflating","k":"2","r":"868.5905","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag."},{"c":"NHL","n":"Stimulator, Electrical, Implanted, For Parkinsonian Symptoms","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":4,"d":"Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication."},{"c":"NHM","n":"Sheet, Recording, Breast Examination","k":"2","r":"884.2990","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination."},{"c":"NHN","n":"Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy","k":"2","r":"890.5500","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":54,"b":0,"e":7,"d":"A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use."},{"c":"NHO","n":"Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)","k":"2","r":"868.1500","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture."},{"c":"NHP","n":"Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)","k":"2","r":"868.1500","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture"},{"c":"NHQ","n":"Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)","k":"2","r":"868.1500","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture"},{"c":"NHS","n":"Assay, Genotype, Hiv Drug Resistance, In Vitro","k":"2","r":"866.3950","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Hiv-1 drug resistance genotyping"},{"c":"NHT","n":"Assay, Nucleic Acid Amplification, Bacillus Anthracis","k":"2","r":"866.3045","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth."},{"c":"NHV","n":"System, Water Purification, General Medical Use","k":"2","r":"876.5665","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing."},{"c":"NHW","n":"Electrode, Pacing And Cardioversion, Temporary, Epicardial","k":"2","r":"870.3680","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days."},{"c":"NHX","n":"Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)","k":"2","r":"866.5775","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":21,"b":0,"e":9,"d":"The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis."},{"c":"NHY","n":"Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus","k":"1","r":"866.3480","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera."},{"c":"NHZ","n":"Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus","k":"1","r":"866.3400","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera."},{"c":"NIA","n":"Assay, Direct, Nucleic Acid Amplification, Influenza Virus","k":"1","r":"866.3330","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"These reagents are nucleic acid primers and probes for the amplification and identification of Influenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera."},{"c":"NIC","n":"Lens, Contact, For Reading Discomfort","k":"2","r":"886.5925","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error."},{"c":"NID","n":"Assay, Proliferation, In Vitro, T Lymphocyte","k":"2","r":"864.5220","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient."},{"c":"NIE","n":"Catheter, Hemodialysis, Triple Lumen, Non-Implanted","k":"2","r":"876.5540","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":38,"d":"Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion."},{"c":"NIF","n":"Catheter, Hemodialysis, Triple Lumen, Implanted","k":"2","r":"876.5540","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion."},{"c":"NIG","n":"System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":19,"d":"An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods."},{"c":"NIH","n":"Disinfectant, Subsystem, Water Purification","k":"2","r":"876.5665","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Disinfectant intended for reprocessing water purification systems for hemodialysis."},{"c":"NII","n":"Disinfectant, Dialysate Delivery System","k":"2","r":"876.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Disinfectant intended for reprocessing dialysate delivery systems."},{"c":"NIJ","n":"System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species","k":"2","r":"866.1640","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology"},{"c":"NIK","n":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":11,"e":153,"d":"These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy."},{"c":"NIM","n":"Stent, Carotid","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":12,"e":25,"d":"Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen"},{"c":"NIN","n":"Stent, Renal","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":5,"e":1,"d":"Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen"},{"c":"NIO","n":"Stent, Iliac","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":15,"e":7,"d":"Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen"},{"c":"NIP","n":"Stent, Superficial Femoral Artery","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":13,"e":86,"d":"Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen"},{"c":"NIQ","n":"Coronary Drug-Eluting Stent","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":16,"e":6,"d":"Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis."},{"c":"NIU","n":"Stent, Superficial Femoral Artery, Drug-Eluting","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":3,"d":"Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis."},{"c":"NIV","n":"Coronary Covered Stent","k":"F","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device."},{"c":"NIX","n":"Hearing Aid, Air Conduction, Transcutaneous System","k":"2","r":"874.3950","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing. It consists of an air conduction hearing aid attached to a surgically fitted tube system. The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear). The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal."},{"c":"NIY","n":"Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis"},{"c":"NIZ","n":"Lens, Iris Reconstruction","k":"3","r":"886.3600","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia."},{"c":"NJA","n":"Accessory, System, External Fixator, Containing Antimicrobial Agent","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire."},{"c":"NJB","n":"Orthosis, Truncal, For Dysmenorrhea","k":"1","r":"890.3490","p":"PM","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache.","x":36},{"c":"NJC","n":"Clip, Vas Deferens","k":"2","r":"878.4300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation."},{"c":"NJD","n":"Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer","k":"2","r":"888.3535","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery."},{"c":"NJE","n":"Intracranial Neurovascular Stent","k":"F","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":7,"d":"An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use."},{"c":"NJF","n":"Antibodies, Anti-Actin, Anti-Smooth Muscle","k":"2","r":"866.5120","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis."},{"c":"NJG","n":"Flasher, Afterimage, Ophthalmic","k":"2","r":"886.1300","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0},{"c":"NJH","n":"Lens, Spectacle (Prescription), For Reading Discomfort","k":"1","r":"886.5844","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"Colored spectacle lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error."},{"c":"NJJ","n":"Tonometer, Analyzer, Ocular Blood Flow","k":"2","r":"886.1930","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume."},{"c":"NJK","n":"Valve, Pulmonary","k":"3","r":"","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":3,"d":"To improve lung function in patients with emphysema"},{"c":"NJL","n":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":269,"d":"This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses."},{"c":"NJM","n":"Bracket, Ceramic, Orthodontic","k":"2","r":"872.5470","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":60,"b":0,"e":1,"d":"An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position."},{"c":"NJO","n":"System, Mycolic Acid Analysis, Mycobacterium Tuberculosis","k":"1","r":"866.3370","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A mycolic acids analysis system is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed and pattern recognition software. The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with extraction and analysis of mycolic acids. Results should be interpreted in conjunction with other laboratory observations and procedures."},{"c":"NJR","n":"Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test","k":"1","r":"866.3740","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":18,"b":0,"e":11,"d":"A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status."},{"c":"NJT","n":"Immunohistochemistry Reagents And Kits","k":"1","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":92,"d":"according to the regs...\"..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin."},{"c":"NJU","n":"Suture, Nonabsorbable, Nitinol","k":"2","r":"878.4495","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Soft tissue approximation."},{"c":"NJV","n":"Test, Albumin Cobalt Binding","k":"2","r":"862.1215","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin."},{"c":"NJW","n":"Control Material, Her-2/Neu, Immunohistochemistry","k":"2","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays."},{"c":"NJZ","n":"Extractor, Vein","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The device is a vein extractor that is pushed through the leg around the vein to effect saphenous vein harvesting. It is like a long apple corer, but instead of taking out the apple core you are taking our someone's saphenous vein."},{"c":"NKA","n":"System, Documentation, Breast Lesion","k":"2","r":"884.2990","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam."},{"c":"NKB","n":"Thoracolumbosacral Pedicle Screw System","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":914,"b":0,"e":182,"d":"Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion."},{"c":"NKC","n":"Tubing/Tubing With Filter, Insufflation, Laparoscopic","k":"1","r":"884.1730","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":3},{"c":"NKE","n":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":6,"e":28,"d":"These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure."},{"c":"NKF","n":"Immunohistochemistry Antibody Assay, C-Kit","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"Identification/Intended Use - The anti-c-KIT primary antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or manual assay. It is indicated as an aid in the selection of GIST patients who may qualify for imatinib mesylate therapy within the context of the patient's clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. The test is not intended as the sole basis for making the diagnosis of GIST and is not intended as the sole basis for selecting imatinib mesylate therapy. A negative result would not necessarily exclude the diagnosis of GIST"},{"c":"NKG","n":"Posterior Cervical Screw System","k":"2","r":"888.3075","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":119,"b":0,"e":6,"d":"Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion."},{"c":"NKI","n":"Goniometer With Electrodes","k":"2","r":"888.1500","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data."},{"c":"NKJ","n":"Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter","k":"1","r":"872.3540","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use."},{"c":"NKK","n":"Needle, Hypodermic, Single Lumen, Reprocessed","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKM","n":"Mitral Valve Repair Devices","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":6,"d":"To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus."},{"c":"NKN","n":"Syringe, Piston, Reprocessed","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKO","n":"System, Balloon, Intra-Aortic And Control, Reprocessed","k":"3","r":"870.3535","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKP","n":"Injector, Contrast Medium, Automatic, Reprocessed","k":"2","r":"870.1650","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0},{"c":"NKQ","n":"Guidewire, Catheter, Reprocessed","k":"2","r":"870.1330","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":1,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKR","n":"System, Catheter Control, Reprocessed","k":"2","r":"870.1290","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKS","n":"Catheter, Steerable, Reprocessed","k":"2","r":"870.1280","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKT","n":"Injector And Syringe, Angiographic, Reprocessed","k":"2","r":"870.1650","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKU","n":"Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed","k":"2","r":"870.1650","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1},{"c":"NKW","n":"Actuator, Syringe, For Injector, Reprocessed","k":"2","r":"870.1670","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKX","n":"Needle, Phacoemulsification, Reprocessed","k":"2","r":"886.4670","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":11,"d":"Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a \"reprocessed\" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKY","n":"Blade, Keratome, Reprocessed","k":"1","r":"886.4370","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NKZ","n":"Endoilluminator, Reprocessed","k":"2","r":"876.1500","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Used intraocularly to provide light into the posterior of the eye during retinal surgery. Same as product code MPA, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLA","n":"Knife, Ophthalmic, Reprocessed","k":"1","r":"886.4350","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLB","n":"Trocar, Tracheal, Laryngeal, Sinus, Reprocessed","k":"1","r":"874.4420","p":"EN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Same as KBG, KAB, and KCI but need one code for reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLC","n":"Bracket, Plastic, Orthodontic, Reprocessed","k":"2","r":"872.5470","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"same as DYW except it is being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLD","n":"Instrument, Diamond, Dental, Reprocessed","k":"1","r":"872.4535","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"same as DZP except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLE","n":"Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed","k":"2","r":"874.4680","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Same as BWH except it is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLF","n":"Oximeter, Reprocessed","k":"2","r":"870.2700","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":27,"b":0,"e":3,"d":"same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLG","n":"Catheter, Intracardiac Mapping, High-Density, Reprocessed","k":"2","r":"870.1220","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLH","n":"Catheter, Recording, Electrode, Reprocessed","k":"2","r":"870.1220","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":70,"b":0,"e":49,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLI","n":"Catheter, Angiography, Reprocessed","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLJ","n":"Stripper, Vein, External, Reprocessed","k":"2","r":"870.4885","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLK","n":"Needle, Biopsy, Cardiovascular, Reprocessed","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLL","n":"Staple, Implantable, Reprocessed","k":"2","r":"878.4750","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLM","n":"Laparoscope, General & Plastic Surgery, Reprocessed","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":23,"b":0,"e":18,"d":"The \"Endoscope and accessories, reprocessed\" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLN","n":"Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed","k":"2","r":"882.4310","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLO","n":"Drills, Burrs, Trephines And Accessories (Manual), Reprocessed","k":"2","r":"882.4300","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLP","n":"Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed","k":"2","r":"882.4305","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLQ","n":"Single-Use Reprocessed Ultrasonic Surgical Instruments","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":27,"b":0,"e":7,"d":"Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLR","n":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed","k":"2","r":"876.4300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLS","n":"Instrument, Biopsy, Reprocessed","k":"2","r":"876.1075","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended to obtain samples of tissue by cutting and/or other mechanical means. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLT","n":"Snare, Flexible, Reprocessed","k":"2","r":"876.4300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLU","n":"Forceps, Biopsy, Electric, Reprocessed","k":"2","r":"876.4300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"The \"forceps, biopsy, electric, reprocessed\" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLV","n":"Electrode, Flexible Suction Coagulator, Reprocessed","k":"2","r":"876.4300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The \"electorde, flexible suction coagulator, reprocessed\" is intended to be used endoscopically to provide simultaneous suction of fluids and coagulation of tissue. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLW","n":"Electrode, Electrosurgical, Active, Urological, Reprocessed","k":"2","r":"876.4300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"The \"electrode, electrosurgical, active, urological, reprocessed\" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf) Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)"},{"c":"NLX","n":"Needle, Pneumoperitoneum, Spring Loaded, Reprocessed","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The \"needle, penum....\" is intended to insufflate the peritoneal cavity with gas during endoscopic procedures. This device is indiated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NLY","n":"Microdebrider, Ent, High Speed, Single Use, Reprocessed","k":"1","r":"874.4140","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)"},{"c":"NLZ","n":"Bur, Ent, Diamond Coated, Single Use, Reprocessed","k":"1","r":"874.4140","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMA","n":"Tube, Tracheal, Reprocessed","k":"2","r":"868.5730","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMB","n":"Catheter, Oximeter, Fiber Optic, Reprocessed","k":"2","r":"870.1230","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMC","n":"Mask, Ventilator, Non-Continuous, Reprocessed","k":"2","r":"868.5905","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessed mask for use with a non-continuous ventilator (CPAP, BiLevel pressure). Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMD","n":"Oximeter, Tissue Saturation, Reprocessed","k":"2","r":"870.2700","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NME","n":"Bur, Diamond Coated, Reprocessed","k":"1","r":"872.3240","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":1,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMF","n":"Clamp, Vascular, Reprocessed","k":"2","r":"870.4450","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMG","n":"Forceps, Biopsy, Gynecological, Reprocessed","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMH","n":"Laparoscope And Accessories, Gynecologic, Reprocessed","k":"2","r":"884.1720","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMI","n":"Laparoscopic Insufflator And Accessories, Reprocessed","k":"1","r":"884.1730","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0},{"c":"NMJ","n":"Clip, Implantable, Reprocessed","k":"2","r":"878.4300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The \"implantable clip, reprocessed\" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMK","n":"Trocar, Reprocessed","k":"2","r":"870.1390","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NML","n":"Catheter, Biliary, Reprocessed","k":"2","r":"876.5010","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"same as \"FGE\" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMM","n":"Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)"},{"c":"NMN","n":"Instrument, Clip, Forming/Cutting, Reprocessed","k":"1","r":"882.4190","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMP","n":"Needle, Isotope, Reprocessed","k":"2","r":"892.5730","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMR","n":"Needle, Spinal, Short Term, Reprocessed","k":"2","r":"868.5150","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMT","n":"Needle, Catheter, Reprocessed","k":"1","r":"878.4200","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMU","n":"Needle, Gastro-Urology, Reprocessed","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMW","n":"Needle, Dental, Reprocessed","k":"1","r":"872.4730","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMX","n":"Needle And Needle Set, Gastro-Urology, Reprocessed","k":"2","r":"876.1075","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NMY","n":"Needle, Endoscopic, Reprocessed","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNA","n":"Biopsy Device, Percutaneous, Reprocessed","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNB","n":"Needle, Reproduction, Assisted, Reprocessed","k":"2","r":"884.6100","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNC","n":"Needle, Aspiration And Needle, Reprocessed","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNE","n":"Needle, Fistula, Reprocessed","k":"2","r":"876.5540","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNG","n":"Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNH","n":"Needle, Conduction, Anesthesia, Reprocessed","k":"2","r":"868.5150","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as \"BSP.\" Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NNI","n":"Container, Specimen, Non-Sterile","k":"1","r":"864.3250","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":4,"x":21},{"c":"NNJ","n":"Gustometer, Non-Sterile","k":"1","r":"874.1500","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"x":23},{"c":"NNK","n":"Container, Specimen Mailer And Storage, Non-Sterile","k":"1","r":"864.3250","p":"PA","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"x":21},{"c":"NNL","n":"Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile","k":"1","r":"864.3250","p":"PA","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"x":21},{"c":"NNN","n":"Crimper, Wire, Ent, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JXT.","x":23},{"c":"NNO","n":"Jig, Piston Cutting, Ent, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JXY.","x":23},{"c":"NNP","n":"Die, Wire Bending, Ent, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JXW.","x":23},{"c":"NNQ","n":"Forceps, Wire Closure, Ent, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JXX.","x":23},{"c":"NNR","n":"Block, Cutting, Ent, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JXS.","x":23},{"c":"NNS","n":"Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code LRE.","x":23},{"c":"NNT","n":"Punch, Gelfoam, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JXZ","x":23},{"c":"NNU","n":"Scissors, Wire Cutting, Ent, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JYA.","x":23},{"c":"NNV","n":"Vise, Ossicular Finger, Non-Sterile","k":"1","r":"874.3540","p":"EN","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Prosthesis modification instrument for ossicular replacement surgery; see product code JYB.","x":23},{"c":"NNW","n":"Bag, Urine Collection, Leg, For External Use, Non-Sterile","k":"1","r":"876.5250","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":2,"d":"Urine collector and accessories; see product code FAQ.","x":3},{"c":"NNX","n":"Device, Incontinence, Urosheath Type, Non-Sterile","k":"1","r":"876.5250","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Urine collector and accessories; see product code EXJ","x":3},{"c":"NNY","n":"Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile","k":"1","r":"876.5250","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":3,"d":"Urine collector and accessories; see product code EYT.","x":3},{"c":"NNZ","n":"System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile","k":"1","r":"876.5250","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"Urine collector and accessories; see product code EYZ.","x":3},{"c":"NOA","n":"Device, Paste-On For Incontinence, Non-Sterile","k":"1","r":"876.5250","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Urine collector and accessories; see product code EXI.","x":3},{"c":"NOB","n":"Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile","k":"1","r":"872.6855","p":"DE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"manual toothbrush; see product code MCF","x":14},{"c":"NOC","n":"Splint, Extremity, Non-Inflatable, External, Non-Sterile","k":"1","r":"878.3910","p":"SU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"Non-inflatable extremity splint; See product code fyh.","x":25},{"c":"NOD","n":"Board, Arm (With Cover), Non-Sterile","k":"1","r":"878.3910","p":"SU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"x":25},{"c":"NOE","n":"Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2","k":"2","r":"866.5600","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":12,"d":"The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein."},{"c":"NOF","n":"System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations","k":"2","r":"872.3661","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":5,"b":0,"e":1,"d":"An optical impression system for cad/cam of dental restorations is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software."},{"c":"NOG","n":"Topographer, Corneal, Battery Powered","k":"1","r":"886.1350","p":"OP","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Topographer, corneal, battery powered","x":28},{"c":"NOH","n":"Photokeratoscope, Battery Powered","k":"1","r":"886.1350","p":"OP","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"external aesthetic restoration prosthesis","x":28},{"c":"NOI","n":"Stand, Instrument, Ophthalmic, Battery Powered","k":"1","r":"886.1860","p":"OP","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position.","x":6},{"c":"NOJ","n":"Prosthesis, Breast, External, No Adhesive","k":"1","r":"878.3800","p":"SU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"external aesthetic restoration prosthesis","x":29},{"c":"NOK","n":"Material, External Aesthetic Restoration, No Adhesive","k":"1","r":"878.3800","p":"SU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"external aesthetic restoration prosthesis","x":29},{"c":"NOM","n":"Antigen, Galactomannan, Aspergillus Spp.","k":"1","r":"866.3040","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":2,"d":"The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis."},{"c":"NON","n":"Forceps, Biopsy, Non-Electric, Reprocessed","k":"1","r":"876.1075","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NOO","n":"Clamp, Dialysis Arm","k":"1","r":"876.5540","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation."},{"c":"NOP","n":"Elisa, Antibody, West Nile Virus","k":"2","r":"866.3940","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":2,"d":"The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients."},{"c":"NOT","n":"Microscope, Automated, Image Analysis, Operator Intervention","k":"2","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":2,"d":"Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention."},{"c":"NOU","n":"Continuous, Ventilator, Home Use","k":"2","r":"868.5895","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":16,"d":"This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device."},{"c":"NOV","n":"Anchor, Suture, Bone Fixation, Metallic","k":"2","r":"888.3030","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim."},{"c":"NOX","n":"Filler, Bone Void, Synthetic Peptide","k":"3","r":"","p":"OR","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":3,"e":4,"d":"The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone."},{"c":"NOY","n":"Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia","k":"2","r":"876.5550","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH)."},{"c":"NOZ","n":"Assay, 1,5-Anhydroglucitol (15ag)","k":"2","r":"864.7470","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes."},{"c":"NPB","n":"System, Monitoring, For Progress Of Labor","k":"2","r":"884.2800","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor."},{"c":"NPE","n":"Material, Embolization, Neurovascular, Polymerizing Or Precipitating","k":"3","r":"","p":"NE","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":1,"d":"This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations."},{"c":"NPF","n":"Monitor, Apnea, Home Use","k":"2","r":"868.2377","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":3,"d":"Same as the identification for product code FLS, just add home use"},{"c":"NPG","n":"Catheter, Infusion, Syringe","k":"2","r":"870.1210","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To provide physician specified fluids both perivascular or intraluminal to the perivascular space."},{"c":"NPH","n":"Antigen, Cartilage Oligomeric Matrix Protein (Comp)","k":"2","r":"866.5775","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"COMP ELISA is a quantitative enzyme-linked immunosorbent assay for detecting COMP (Cartilage Oligomeric Matrix Protein) in patient sera. The presence of elevated levels, when considered in conjunction with other laboratory and clinical findings, aids in identifying aggressive destruction of joint tissue in Rheumatoid Arthritis."},{"c":"NPJ","n":"Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","k":"2","r":"888.3560","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":9,"d":"The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement."},{"c":"NPK","n":"Barrier, Synthetic, Intraoral","k":"2","r":"872.3930","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":31,"b":0,"e":1,"d":"A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials."},{"c":"NPL","n":"Barrier, Animal Source, Intraoral","k":"2","r":"872.3930","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":57,"b":0,"e":11,"d":"An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants."},{"c":"NPM","n":"Bone Grafting Material, Animal Source","k":"2","r":"872.3930","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":42,"b":1,"e":11,"d":"A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw."},{"c":"NPO","n":"Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody","k":"2","r":"866.3045","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth"},{"c":"NPP","n":"Reprocessed Blood Pressure Cuff","k":"2","r":"870.1120","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement."},{"c":"NPQ","n":"Test, Factor V Leiden Mutations, Genomic Dna Pcr","k":"2","r":"864.7280","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":14,"d":"In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia."},{"c":"NPR","n":"Test, Factor Ii G20210a Mutations, Genomic Dna Pcr","k":"2","r":"864.7280","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":2,"d":"In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia."},{"c":"NPS","n":"Tricuspid Valve Repair Device, Percutaneously Delivered","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation."},{"c":"NPT","n":"Aortic Valve, Prosthesis, Percutaneously Delivered","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":8,"e":36,"d":"To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement."},{"c":"NPU","n":"Prosthesis, Mitral Valve, Percutaneously Delivered","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":3,"e":1,"d":"These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement."},{"c":"NPV","n":"Pulmonary Valve Prosthesis Percutaneously Delivered","k":"F","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":3,"e":2,"d":"These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement."},{"c":"NPW","n":"Percutaneously Delivered Prostheses And Tricuspid Valves","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement."},{"c":"NPZ","n":"Bone Grafting Material, Dental, With Biologic Component","k":"3","r":"872.3930","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":3,"e":1,"d":"Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region."},{"c":"NQA","n":"Biologic Material, Dental","k":"3","r":"872.3930","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":7,"d":"Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region."},{"c":"NQB","n":"Conformer, Ophthalmic, Biological Tissue","k":"2","r":"886.3130","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":3,"d":"The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures."},{"c":"NQC","n":"Test, Breath Analysis, Volatile Organic Compounds","k":"F","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Breath analysis test for use as an aid in the diagnosis of grade 3 heart transplant rejection in first year heart recipient patients"},{"c":"NQD","n":"Cardiac C-Reactive Protein, Antigen, Antiserum, And Control","k":"2","r":"866.5270","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":19,"b":0,"e":3,"d":"In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments."},{"c":"NQE","n":"Microscope, Specular","k":"2","r":"886.1850","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":2,"d":"Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro."},{"c":"NQF","n":"Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The epidermal growth factor receptor (EGFR) antibody/assay is a qualitative immunohistochemical antibody/assay to identify EGFR expression in normal and neoplastic tissues routinely-fixed for histological evaluation. EGFR antibody/assay specifically detects the EGFR (HER1) protein in EGFR-expressing cells. This antibody/assay is indicated as an aid in identifying colorectal cancer patients eligible for treatment with cetuximab, a monoclonal antibody drug. This will be a specialized subcategory for EGFR immunohistochemistry assays under the general heading of the regulation for all Immunohistochemistry assays."},{"c":"NQG","n":"Stabilizer, Heart, Non-Compression, Reprocessed","k":"1","r":"870.4500","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NQH","n":"Sensor, Pressure, Aneurysm, Implantable","k":"2","r":"870.2855","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure."},{"c":"NQI","n":"System, Immunomagnetic, Circulating Cancer Cell, Enumeration","k":"2","r":"866.6020","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":9,"d":"In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival."},{"c":"NQJ","n":"Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use","k":"2","r":"876.5540","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload."},{"c":"NQK","n":"Maggots, Medical","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":6,"b":0,"e":1,"d":"Phaenicia sericacta (blow fly) larvae are harvested and provided disinfected for use in debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds. See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702)"},{"c":"NQL","n":"System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry","k":"2","r":"862.1055","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":3,"d":"Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders."},{"c":"NQM","n":"Immunoassay For Detection Of Amniotic Fluid Protein(S).","k":"1","r":"862.1550","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":2,"b":0,"e":3,"d":"The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture."},{"c":"NQN","n":"Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity","k":"2","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":15,"b":0,"e":4,"d":"Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention."},{"c":"NQO","n":"Prosthesis, Spinous Process Spacer/Plate","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":4,"e":6,"d":"This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process."},{"c":"NQP","n":"Posterior Metal/Polymer Spinal System, Fusion","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":22,"b":0,"e":50,"d":"This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine."},{"c":"NQQ","n":"System, Imaging, Optical Coherence Tomography (Oct)","k":"2","r":"892.1560","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":46,"b":0,"e":3,"d":"This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging."},{"c":"NQR","n":"Sealant, Dural","k":"3","r":"","p":"NE","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":5,"e":0,"d":"Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place."},{"c":"NQS","n":"Bracket, Metal, Orthodontic, Reprocessed","k":"1","r":"872.5410","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NQT","n":"Dislodger, Stone, Flexible, Ureteral, Reprocessed","k":"2","r":"876.4680","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A ureteral stone dislodger is a device that consists of a bougie or a catheter with a special flexible tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NQU","n":"Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed","k":"2","r":"876.4680","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NQV","n":"Catheter, Suction, Tracheobronchial, Reprocessed","k":"1","r":"876.4680","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NQW","n":"Orthosis, Spine, Plate, Laminoplasty, Metal","k":"2","r":"888.3050","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":30,"b":0,"e":0,"d":"This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure."},{"c":"NQX","n":"System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen","k":"2","r":"866.1640","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":24,"b":0,"e":20,"d":"A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings."},{"c":"NQY","n":"Ventilator, Continuous, Minimal Ventilatory Support, Home Use","k":"2","r":"868.5895","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home."},{"c":"NQZ","n":"Antigen, Invasive Fungal Pathogens","k":"2","r":"866.3050","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":2,"d":"Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination."},{"c":"NRA","n":"Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":32,"d":"This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis."},{"c":"NRB","n":"Wound Cleaner, Ultrasound","k":"2","r":"878.4410","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound"},{"c":"NRC","n":"Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile","k":"1","r":"884.5425","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, not intended as intralabial pads or reusable menstrual pads. These are made of common cellulosic or synthetic material with an established safety profile."},{"c":"NRD","n":"Unit, Operative Dental, Accessories","k":"1","r":"872.6640","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit."},{"c":"NRF","n":"Material, Quality Control, Semen Analysis","k":"2","r":"864.8625","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":1,"d":"A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells."},{"c":"NRH","n":"System, Breath Measurement","k":"1","r":"862.1820","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":4,"b":0,"e":3,"d":"Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions."},{"c":"NRI","n":"Autoantibodies, Nuclear Pore Glycoprotein Gp210","k":"2","r":"866.5090","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis."},{"c":"NRJ","n":"Ultrasound, Skin Permeation","k":"2","r":"878.4410","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc."},{"c":"NRK","n":"Kit, Test, Olfactory","k":"2","r":"874.1600","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card. The device is intended for screening neurological disorder."},{"c":"NRL","n":"Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis","k":"2","r":"866.3045","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax."},{"c":"NRN","n":"Leeches, Medicinal","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":3,"b":0,"e":0,"d":"The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. The animal is a bloodsucking aquatic animal living in fresh water. The device should be indicated as: \"an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding.\" See Federal Register Notice at 89 FR 106521 “Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches” (FRN) (FDA-2024-N-5702)"},{"c":"NRP","n":"Sirolimus Test System","k":"2","r":"862.3840","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":6,"d":"Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus."},{"c":"NRQ","n":"Blade-Form Endosseous Dental Implant","k":"2","r":"872.3640","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function."},{"c":"NRS","n":"Control Material, Blood Circulating Epithelial Cancer Cell","k":"2","r":"864.8625","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":1,"d":"The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells."},{"c":"NRU","n":"Chair, Dental, Without Operative Unit","k":"1","r":"872.6250","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":4,"d":"A dental chair is a device, usually powered, that is intended to seat a patient in the proper position to perform a dental procedure."},{"c":"NRV","n":"Implantable Radio Frequency Transponder System","k":"2","r":"880.6300","p":"HO","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient"},{"c":"NRW","n":"Stimulator, Intramuscular, Automatic","k":"2","r":"880.5580","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The Automatic Intramuscular Stimulator is a device that aids muscle stimulation by using a method called dry needling for treatment. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter. The motor unit has a mounted disposal syringe and a needle mounting hardware for a disposable needle, and enables the practitioner to administer treatment with less physical effort. An EMG needle is used instead of an acupuncture needle because it is less flexible than the acupuncture needle"},{"c":"NRX","n":"Complement 4d (C4d) And Complement Receptor 1 (Cr1)","k":"2","r":"866.5820","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus."},{"c":"NRY","n":"Catheter, Thrombus Retriever","k":"2","r":"870.1250","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":117,"b":0,"e":27,"d":"The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode."},{"c":"NRZ","n":"Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided","k":"3","r":"","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure."},{"c":"NSA","n":"Over-The-Counter Automated External Defibrillator","k":"3","r":"870.5310","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":1,"b":2,"e":2,"d":"Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs."},{"c":"NSB","n":"Patient Personal Hygiene Kit","k":"1","r":"872.6855","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":16,"d":"This device contains items given to an individual during their hospital stay.","x":14},{"c":"NSC","n":"Injector, Pen","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient."},{"c":"NSD","n":"Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"In vitro diagnostic test to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons suspected of having bladder cancer. It is an adjunctive test for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequently monitoring for tumor recurrence in patients previously diagnosed with bladder cancer."},{"c":"NSF","n":"Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment","k":"2","r":"866.6030","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld). Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months. Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the existing hcc practice guidelines in oncology."},{"c":"NSI","n":"System, Imaging, Esophageal, Wireless, Capsule","k":"2","r":"876.1300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL."},{"c":"NSJ","n":"Restoration, Noble Metal","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"","a":0,"b":0,"e":0,"d":"Foreign dental lab manufactured noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals."},{"c":"NSK","n":"Dentures, Partial","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Foreign dental lab manufactured partial dentures are manufactured as finished products from denture resins and other supporting materials."},{"c":"NSL","n":"Dentures, Full","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Foreign dental lab manufactured full dentures are manufactured as finished products from denture resins."},{"c":"NSM","n":"Restoration, Resin","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins."},{"c":"NSN","n":"Restoration, Resin, Crown And Bridge","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Foreign dental lab manufactured resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins."},{"c":"NSO","n":"Restoration, Porcelain-Fused-To-Metal","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Foreign dental lab manufactured porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys."},{"c":"NSP","n":"Restoration, Porcelain","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains."},{"c":"NSQ","n":"Restoration, Base Metal","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"Foreign dental lab manufactured base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals."},{"c":"NSR","n":"Prosthesis, Orthodontic","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis."},{"c":"NSS","n":"Electronic Media, Nausea","k":"N","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Treatment of nausea and vomiting associated with morning sickness and motion sickness."},{"c":"NST","n":"Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM, INTERFERES WITH THE BINDING OF ACETYLCHOLINE, A NEURAL TRANSMITTER AT THE JUNCTION OF NERVES WITH MUSCLES. AUTOANTIBODY CAN ALSO BIND TO OTHER PORTIONS OF THE ACETYLCHOLINE RECEPTOR WITHOUT INTERFERING WITH ACETYLCHOLINE BINDING. PRESENCE OF AUTOANTIBODY ALONG WITH CLINICAL SIGNS AND SYMPTOMS ARE USUALLY HIGHLY SUGGESTIVE OF MYASTHENIA GRAVIS. ACETYLCHOLINE RECEPTOR AUTOANTIBODY CAN ALSO OCCUR IN THE PRESENCE OF AUTOANTIBODIES TO OTHER BODY SUBSTANCES."},{"c":"NSU","n":"Instrumentation For Clinical Multiplex Test Systems","k":"2","r":"862.2570","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":13,"b":0,"e":14,"d":"Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de"},{"c":"NTB","n":"System, Ablation, Ultrasound And Accessories","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery."},{"c":"NTC","n":"Nursing Pad, Hydrogel","k":"1","r":"880.5630","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0},{"c":"NTE","n":"Temporary Carotid Catheter For Embolic Capture","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":36,"b":0,"e":30,"d":"This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i"},{"c":"NTG","n":"Prosthesis, Ankle, Uncemented, Non-Constrained","k":"3","r":"","p":"OR","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":4,"d":"An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene."},{"c":"NTH","n":"System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays","k":"2","r":"866.4700","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0},{"c":"NTI","n":"Drug Metabolizing Enzyme Genotyping Systems","k":"2","r":"862.3360","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":11,"b":0,"e":4,"d":"Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system."},{"c":"NTK","n":"Light Transmission Caries Detector","k":"2","r":"872.1745","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":0},{"c":"NTM","n":"Antigen, Inflammatory Response Marker, Sepsis","k":"2","r":"866.3210","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma."},{"c":"NTN","n":"Led Light Source","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":9,"b":0,"e":0,"d":"Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals"},{"c":"NTO","n":"Rinse, Oral, Antibacterial (By Physical Means)","k":"2","r":"872.5580","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":2,"d":"Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion."},{"c":"NTR","n":"Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells","k":"1","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":1,"d":"MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS."},{"c":"NTU","n":"Evoked Potential Stimulator, Thermal","k":"2","r":"882.1870","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Intended to evaluate the functionality of human pain reception and transmission of sensory pathways"},{"c":"NTV","n":"Myeloperoxidase, Immunoassay, System, Test","k":"2","r":"866.5600","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK FOR MAJOR ADVERSE CARDIAC EVENTS, INCLUDING MYOCARDIAL INFARCTION, NEED FOR REVASCULARIZATION, OR DEATH."},{"c":"NTW","n":"System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test","k":"2","r":"866.4070","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing"},{"c":"NTX","n":"Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)","k":"1","r":"880.5630","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A NURSING PAD CONSISTING OF A POLYURETHANE PAD WITH GLYCERIN USED TO RELIEVE NIPPLES THAT ARE SORE AND CRACKED FROM BREASTFEEDING."},{"c":"NTY","n":"System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES."},{"c":"NTZ","n":"Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate."},{"c":"NUA","n":"System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection","k":"2","r":"866.5900","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":2,"d":"The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening."},{"c":"NUB","n":"Colonic Irrigation System, General Well Being","k":"3","r":"876.5220","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being"},{"c":"NUC","n":"Lubricant, Personal","k":"2","r":"884.5300","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":249,"b":0,"e":7,"d":"This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms."},{"c":"NUD","n":"Vertebroplasty Compound, Calcium Based","k":"2","r":"888.3027","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS."},{"c":"NUF","n":"Catheter, Neurovasculature, Occluding Balloon","k":"3","r":"882.5150","p":"NE","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management"},{"c":"NUH","n":"Stimulator, Nerve, Transcutaneous, Over-The-Counter","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":231,"b":0,"e":0,"d":"TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES"},{"c":"NUI","n":"Ultrasound, Infusion, System","k":"2","r":"870.1200","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature."},{"c":"NUJ","n":"Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":37,"b":0,"e":20,"d":"Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)."},{"c":"NUK","n":"For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":1},{"c":"NUL","n":"For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0},{"c":"NUM","n":"Autoantibodies, Nuclear Body Protein, Sp100","k":"2","r":"866.5090","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS."},{"c":"NUN","n":"Bone Grafting Material, Human Source","k":"2","r":"872.3930","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":15,"b":0,"e":0,"d":"INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION."},{"c":"NUP","n":"Cream, Nasal, Topical, Mechanical Allergen Particle Barrier","k":"2","r":"880.5045","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS."},{"c":"NUQ","n":"Pad, Menstrual, Reusable","k":"1","r":"884.5435","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A reusable, unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile."},{"c":"NUR","n":"Pad, Menstrual, Intralabial","k":"1","r":"884.5435","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"An unscented menstrual pad intended as an intralabial pad, which is placed over the vaginal introitus to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile."},{"c":"NUU","n":"Lens, Contact, Orthokeratology, Overnight","k":"3","r":"886.5916","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":7,"e":2,"d":"Temporary reduction of myopia or refractive error."},{"c":"NUV","n":"Massager, Vacuum, Light Induced Heating","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":20,"b":0,"e":0,"d":"The device is intended to temporarily alter the appearance of cellulite"},{"c":"NUW","n":"Stimulator, Muscle, Powered, Dental","k":"2","r":"890.5850","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow."},{"c":"NUX","n":"Cleanser, Denture, Prescription","k":"1","r":"872.3520","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Effervescent tablet for the removal of micro-organisms from removable dentures and retainers."},{"c":"NVA","n":"Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES."},{"c":"NVB","n":"Intraocular, Pressure Measuring Device","k":"3","r":"886.4280","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma."},{"c":"NVC","n":"Bone, Heterograft","k":"3","r":"888.3015","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN."},{"c":"NVE","n":"Washer, Cleaner, Automated, Endoscope","k":"2","r":"876.1500","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":1,"d":"This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the endoscopes."},{"c":"NVG","n":"Tissue Culture, Accessories, Dental","k":"1","r":"864.2240","p":"HE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Intended to temporarilty nourish cells on an avulsed tooth","x":41},{"c":"NVH","n":"Suture, Knot, Mechanical","k":"2","r":"878.4300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"In approximation and/or ligation of soft tissue"},{"c":"NVI","n":"Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease","k":"2","r":"862.3100","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests."},{"c":"NVJ","n":"Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility."},{"c":"NVK","n":"Laser, Dental, Soft Tissue","k":"2","r":"878.4810","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":17,"b":0,"e":2,"d":"Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry."},{"c":"NVM","n":"Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":2,"d":"Percutaneous transluminal angioplasty of peripheral vasculature exclusive of coronary arteries"},{"c":"NVN","n":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":15,"e":0,"d":"Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart."},{"c":"NVO","n":"Spacer, Direct Patient Interface","k":"2","r":"868.5630","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Spacers are devices that are used with nebulizers and metered dose inhalers that are comprised of a reservior into which an aerosol medication is dispensed. A spacer uses an open mouthpiece. Spacers are intended to minimize delivery of large aerosolized particles."},{"c":"NVP","n":"Holding Chambers, Direct Patient Interface","k":"2","r":"868.5630","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":16,"b":0,"e":3,"d":"Holding chambers are devices that are used with nebulizers and metered dose inhalers and are comprised of a reservoir into which an aerosol medication is dispensed. A holding chamber uses a valved mouthpiece through which the patient inhales the dispensed medication. Holding chambers are intended to minimize delivery of large aerosolized particles"},{"c":"NVQ","n":"Bacteriophage And Controls, B. Anthracis Lysis","k":"2","r":"866.3045","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage."},{"c":"NVR","n":"Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":6,"b":0,"e":17,"d":"Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion, please reference: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion."},{"c":"NVT","n":"Tubing And Tubing/Filter Fits","k":"1","r":"884.1700","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope."},{"c":"NVV","n":"Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System","k":"1","r":"862.2100","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images."},{"c":"NVY","n":"Permanent Defibrillator Electrodes","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":19,"e":6,"d":"Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle."},{"c":"NVZ","n":"Pulse Generator, Permanent, Implantable","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":16,"e":43,"d":"Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart."},{"c":"NWA","n":"Prosthesis, Tracheal, Preformed/Molded","k":"2","r":"878.3720","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"The device is intended to provide support to weakened or constricting airway walls."},{"c":"NWB","n":"Endoscope, Accessories, Narrow Band Spectrum","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":19,"d":"Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract."},{"c":"NWE","n":"Colon Computed Tomography System, Computer Aided Detection","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review."},{"c":"NWF","n":"Drill, Battery Powered, Subungual Hematoma","k":"1","r":"878.4820","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed. Indicated to relieve pressure from subungual hematomas (including black toe)."},{"c":"NWG","n":"Autoantibodies, Glutamic Acid Decarboxylase (Gad)","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes)."},{"c":"NWI","n":"Electrosurgical Electrode Kit","k":"2","r":"876.4300","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"NWJ","n":"Suture, Recombinant Technology","k":"2","r":"878.4494","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":1,"d":"Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation."},{"c":"NWM","n":"Immunoassay, Anti-Seizure Drug","k":"2","r":"862.3350","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"To aid in management of patients treated with anti-seizure drug."},{"c":"NWN","n":"Laparoscopic Bone Anchor Urethropexy Instrument Kit","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NWO","n":"Kit, Catheter, Urinary (Exludes Hiv Testing)","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":3,"d":"Urinary Catheterization Kit (Excludes HIV Testing)"},{"c":"NWP","n":"Suprapubic Cystostomy Catheter Kit","k":"2","r":"876.5090","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NWS","n":"Kit, Choledochoscope, Flexible And Rigid","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Flexible and Rigid Choledochoscope Kit"},{"c":"NWT","n":"Endoscopic Cholangiogram Kit","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NWU","n":"Endoscope Introducer Kit","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":3,"b":0,"e":25,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"NWV","n":"Laparoscopic Accessories, Gynecologic","k":"1","r":"884.1720","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":7,"d":"Exempt laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts."},{"c":"NWW","n":"Hysteroscope Accessories","k":"1","r":"884.1690","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts."},{"c":"NWX","n":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":4,"e":3,"d":"To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion."},{"c":"NWY","n":"Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":2,"d":"Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood."},{"c":"NWZ","n":"Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids","k":"2","r":"866.3045","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Aid in the identification of Bacillus Anthracis"},{"c":"NXA","n":"Tracheotomy Care Kit","k":"2","r":"868.5800","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":1,"b":0,"e":12,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NXB","n":"Dispenser, Solid Medication","k":"1","r":"890.5050","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":1,"d":"A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.","x":35},{"c":"NXC","n":"Aligner, Sequential","k":"2","r":"872.5470","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":145,"b":0,"e":2,"d":"The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion."},{"c":"NXD","n":"Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna","k":"2","r":"866.3332","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments aids in the diagnosis of influenza caused by novel influenza a viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza a viruses and provide epidemiological information on influenza. These reagents are primers and probes, along with a specific novel influenza virus control."},{"c":"NXE","n":"Walker, Mechanical, Poly Vinyl Chloride (Pvc)","k":"1","r":"890.3825","p":"PM","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.","x":36},{"c":"NXF","n":"Gas, Laser Generating","k":"1","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Special laser gas mixtures used as a lasing medium"},{"c":"NXG","n":"Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen."},{"c":"NXH","n":"Nursing Pad, Cohesive Gel","k":"1","r":"880.5630","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to relieve nipples that are sore and cracked from breast feeding."},{"c":"NXJ","n":"Denture, Cosmetic Only","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Intended to improve an individual's appearance only. Not intended to assist in chewing food."},{"c":"NXM","n":"Prosthesis, Eyelid Spacer/Graft, Biologic","k":"2","r":"886.3130","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid."},{"c":"NXO","n":"Calprotectin, Fecal","k":"2","r":"866.5180","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":15,"b":0,"e":3,"d":"The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome."},{"c":"NXQ","n":"Reminder, Medication","k":"1","r":"890.5050","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":1,"d":"A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules. The device may incorporate wireless communication.","x":35},{"c":"NXR","n":"Fixation, Vision Training, Binocular","k":"1","r":"886.1290","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation. To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag."},{"c":"NXT","n":"Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":3,"e":6,"d":"Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision."},{"c":"NXV","n":"Diagnostic Light, Soft Tissue Detector","k":"2","r":"872.6350","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities"},{"c":"NXW","n":"Scaffold, Infrapopliteal, Absorbable","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries."},{"c":"NXX","n":"Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus","k":"1","r":"866.3700","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":4,"b":0,"e":1,"d":"The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6)."},{"c":"NXZ","n":"Dental Hygiene Kit","k":"1","r":"872.6855","p":"DE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.","x":14},{"c":"NYC","n":"Dental Prophylaxis Kit","k":"1","r":"872.4565","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NYD","n":"Endodontic Kit","k":"2","r":"872.3820","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NYE","n":"Fixture Mount Kit","k":"1","r":"872.3980","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NYF","n":"Gingival Retraction Kit","k":"1","r":"872.4565","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NYG","n":"Lapping Tool Kit","k":"1","r":"872.4565","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NYH","n":"Plaque Disclosing Kit","k":"2","r":"872.1740","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":1,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"NYI","n":"Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer","k":"2","r":"866.6040","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":1,"d":"A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer."},{"c":"NYK","n":"Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)","k":"2","r":"886.1385","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye."},{"c":"NYL","n":"Handpiece, Air-Powered, Root Canal Irrigation","k":"1","r":"872.4200","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"To clean the root canal prior to filling and used for root canal irrigation."},{"c":"NYN","n":"Stimulator, Electrical, Transcutaneous, For Arthritis","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis)."},{"c":"NYO","n":"Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody","k":"2","r":"866.5100","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use."},{"c":"NYQ","n":"Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer","k":"2","r":"864.1890","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":4,"e":6,"d":"This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy. Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a qualified pathologist."},{"c":"NYS","n":"Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)","k":"2","r":"878.4015","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing. The device consists of a textile substrate and permanently bound pdadmac. The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body."},{"c":"NYT","n":"Prosthesis, Tracheal, Expandable, Polymeric","k":"2","r":"878.3720","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted."},{"c":"NYU","n":"Catheter, Hemodialysis, Implanted, Coated","k":"2","r":"876.5540","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":30,"d":"Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis."},{"c":"NYV","n":"Gastrointestinal Motility System, Capsule","k":"2","r":"876.1725","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders."},{"c":"NYW","n":"Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Nerve stimulation for relief of pain"},{"c":"NYX","n":"Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Electrical stimulation for aesthetic purposes"},{"c":"NYY","n":"Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation","k":"2","r":"890.5850","p":"PM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Used for muscle stimulation for rehabilitation. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area. Indicated for use as an adjunctive therapy in rehabilitation for medical purposes such as relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis."},{"c":"NYZ","n":"Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning","k":"2","r":"890.5850","p":"PM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance."},{"c":"NZA","n":"Accessories, Germicide, Cleaning, For Endoscopes","k":"2","r":"876.1500","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":11,"b":0,"e":1,"d":"High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"NZB","n":"Quality Control Material, Genetics, Dna","k":"2","r":"866.5910","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":4,"b":0,"e":0,"d":"Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls."},{"c":"NZC","n":"Stent, Urethral, Prostatic, Semi-Permanent","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine. The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis. For short term use in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment."},{"c":"NZD","n":"Stretcher, Patient Restraint","k":"1","r":"880.6900","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":2,"d":"Soft restraints to be attached to a backboard or stretcher in order to immobilize the patient in emgency situations.","x":32},{"c":"NZE","n":"Hyperthermia Monitor","k":"2","r":"870.5900","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":1,"d":"Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions)."},{"c":"NZF","n":"Static Electricity-Emitting Device, Cosmetic Use","k":"N","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Intended for relaxation and cosmetic use."},{"c":"NZG","n":"Bassinet, Hospital","k":"2","r":"880.5145","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":2,"d":"Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery."},{"c":"NZH","n":"Medication Management System, Remote","k":"2","r":"880.6315","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic."},{"c":"NZJ","n":"Respirator, N95, For Use By The General Public In Public Health Medical Emergencies","k":"2","r":"880.6260","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":2,"d":"It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids."},{"c":"NZK","n":"Stimulator, Low Electric Field, Tumor Treatment","k":"3","r":"","p":"NE","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status."},{"c":"NZP","n":"Sealant, Microbial","k":"2","r":"878.4370","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Intended to isolate the site of a surgical incision from microbial contamination and indicated to reduce the risk of skin flora contamination of the surgical incision throughout a surgical procedure."},{"c":"NZS","n":"Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast","k":"1","r":"866.2660","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":0,"d":"Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast."},{"c":"NZT","n":"Dosimeter, Ionizing Radiation, Implanted","k":"2","r":"892.5050","p":"RA","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":5,"d":"Verify radiation dose to organs from external radiation therapy."},{"c":"NZU","n":"Collector, Urine, Powered, Non Indwelling Catheter","k":"1","r":"876.5250","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":1,"d":"For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.","x":3},{"c":"NZW","n":"Heparin, Vascular Access Flush","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":44,"d":"Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use."},{"c":"NZX","n":"Water, Vascular Access Flush","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use."},{"c":"NZY","n":"Light, Lymphedema Reduction, Low Energy","k":"2","r":"890.5500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema."},{"c":"OAA","n":"Aid, Visual, For Nausea","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"To relieve the symptoms associated with motion sickness."},{"c":"OAB","n":"Low Energy Direct Current Thermal Ablation System","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":15,"b":0,"e":4,"d":"Ablation of soft tissue"},{"c":"OAC","n":"Plethysmograph, Air Displacement For Body Composition Analysis","k":"2","r":"870.2770","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass)."},{"c":"OAD","n":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":9,"e":22,"d":"For the treatment of atrial flutter."},{"c":"OAE","n":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":10,"e":34,"d":"For the treatment of atrial fibrillation."},{"c":"OAF","n":"Implant, Hearing, Active, Middle Ear, Totally Implanted","k":"3","r":"","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":2,"d":"Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%."},{"c":"OAG","n":"Garment, Storage, Peritoneal Dialysis Catheter","k":"1","r":"890.5050","p":"GU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To store the external peritoneal catheter portion between treatment sessions and to support, stabilize, and improve the care and cleanliness of the peritoneal catheter and reduce the need to use tape on the skin.","x":35},{"c":"OAH","n":"Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis","k":"1","r":"866.3740","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":4,"b":0,"e":1,"d":"E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains."},{"c":"OAI","n":"Assay, Enterovirus Nucleic Acid","k":"2","r":"866.3225","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus."},{"c":"OAJ","n":"Catheter, Drainage, Intraoral/Extraoral","k":"1","r":"878.4200","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones"},{"c":"OAL","n":"Exercise Equipment, Powered, Emg-Triggered","k":"2","r":"890.1375","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education."},{"c":"OAM","n":"Immunoassay, Insulin-Like Growth Factor Binding Protein-1","k":"1","r":"862.1550","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":1,"d":"The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women."},{"c":"OAN","n":"Orthosis, Cranial, Laser Scan","k":"2","r":"882.5970","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":23,"b":0,"e":0,"d":"A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads."},{"c":"OAO","n":"Cord Blood Processing System And Storage Container","k":"2","r":"864.9900","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A cord blood processing system and storage container is a device intended for use in the processing and the storage of cord blood. This device is used as a functionally closed processing system by cord blood establishments. This device includes containers, other soft goods, and centrifugation systems for cord blood product concentration, and a final container for the cryopreservation and the storage of cord blood products."},{"c":"OAP","n":"Laser, Comb, Hair","k":"2","r":"890.5500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":115,"b":0,"e":1,"d":"Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v"},{"c":"OAQ","n":"Electronic Media, Hyperacusis","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"To improve sound tolerances."},{"c":"OAR","n":"Injector, Vertebroplasty (Does Not Contain Cement)","k":"1","r":"888.4200","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":26,"d":"Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma)."},{"c":"OAS","n":"X-Ray, Tomography, Computed, Dental","k":"2","r":"892.1750","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":136,"b":0,"e":7,"d":"Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth."},{"c":"OAT","n":"Implant, Endosseous, Orthodontic","k":"2","r":"872.3640","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":52,"b":0,"e":3,"d":"It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed."},{"c":"OAU","n":"Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma","k":"2","r":"866.6030","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma."},{"c":"OAV","n":"Mycophenolic Acid Test System","k":"2","r":"862.3840","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients."},{"c":"OAW","n":"Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma","k":"F","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":1,"d":"A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data."},{"c":"OAX","n":"Plasmodium Spp. Detection Reagents","k":"2","r":"866.3402","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the detection of plasmodium spp. Antigens in venous or capillary whole blood. To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plasmodium species."},{"c":"OAY","n":"Light Source System, Diagnostic Endoscopic","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test."},{"c":"OAZ","n":"One-Way Air-Leak Valve","k":"F","r":"","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise."},{"c":"OBA","n":"Polymerizing, Neurovascular Embolization Material","k":"F","r":"","p":"NE","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ."},{"c":"OBB","n":"Kit, Conception-Assist, Home Use","k":"2","r":"884.5250","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 \"sperm friendly\" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope."},{"c":"OBC","n":"Occluder, Internal Vessel, Temporary","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":18,"d":"For temporarily occluding vessels during anastomosis procedures."},{"c":"OBD","n":"Barrier, Adhesion, Cardiovascular","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Indicated to reduce the incidence, severity or extent of adhesions/tissue attachment in cardiovascular surgery by providing a plane of dissection or mechanical barrier between opposing surfaces of tissue and/or devices. Intended for use in cardiac surgery to prevent or reduce adhesions, and facilitate reoperation in patients who are anticipated to need staged cardiovascular surgeries or repeat procedures in the thoracic region."},{"c":"OBE","n":"Anti-Ss-A 52 Autoantibodies","k":"2","r":"866.5100","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis."},{"c":"OBF","n":"Assay, Genotyping, Hepatitis C Virus","k":"2","r":"866.3170","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":2,"e":0,"d":"In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes"},{"c":"OBH","n":"Monitor, Extracellular Fluid, Lymphedema, Extremity","k":"2","r":"870.2770","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":1,"d":"Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)"},{"c":"OBI","n":"Catheter, Pressure Monitoring, Cardiac","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"To measure pressure within the cardiovascular system."},{"c":"OBJ","n":"Catheter, Ultrasound, Intravascular","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":80,"b":0,"e":23,"d":"For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology."},{"c":"OBK","n":"Port, Protector/Cushion","k":"2","r":"880.5965","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports."},{"c":"OBL","n":"Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty","k":"2","r":"888.3027","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height."},{"c":"OBM","n":"Cement, Bone, Vertebroplasty, Pre-Formed, Modular","k":"2","r":"888.3027","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height."},{"c":"OBN","n":"Humidifier, Respiratory, Mask (Direct Patient Interface)","k":"2","r":"868.5450","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated."},{"c":"OBO","n":"Tomography, Optical Coherence","k":"2","r":"886.1570","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":67,"b":0,"e":12,"d":"Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases."},{"c":"OBP","n":"Transcranial Magnetic Stimulator","k":"2","r":"882.5805","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":69,"b":0,"e":6,"d":"A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder."},{"c":"OBR","n":"Mouthguard, Over-The-Counter","k":"U","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":47,"b":0,"e":0,"d":"To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding."},{"c":"OBT","n":"Plate, Bone, Growth Control, Pediatric, Epiphysiodesis","k":"2","r":"888.3030","p":"OR","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":1,"d":"Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused."},{"c":"OBV","n":"Eating Disorder Conditioning Tool","k":"2","r":"882.5060","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient."},{"c":"OBW","n":"11-Dehydro Thromboxane B2 Kit, Urinary","k":"2","r":"864.5700","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only."},{"c":"OBY","n":"Condom, Female, Animal Tissue","k":"3","r":"884.5330","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes."},{"c":"OBZ","n":"Alpha-1-Antitrypsin Kit, Qualitative Phenotype","k":"2","r":"866.5130","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only."},{"c":"OCB","n":"Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection","k":"3","r":"","p":"IM","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required."},{"c":"OCC","n":"Respiratory Virus Panel Nucleic Acid Assay System","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":81,"b":0,"e":25,"d":"A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus."},{"c":"OCE","n":"Cultured Epithelial Autograft","k":"F","r":"","p":"SU","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns."},{"c":"OCF","n":"Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). Relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis)."},{"c":"OCG","n":"Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented","k":"3","r":"888.3410","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head."},{"c":"OCH","n":"Oximeter, Infrared, Sporting, Aviation","k":"2","r":"870.2700","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise."},{"c":"OCI","n":"Indicator, Physical/Chemical, Storage Temperature","k":"2","r":"880.2800","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile."},{"c":"OCJ","n":"Spinal Channeling Instrument, Vertebroplasty","k":"1","r":"888.4540","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":2,"d":"Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions."},{"c":"OCK","n":"Transurethral Occlusion Insert, Urinary Incontinence-Control, Female","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":8,"d":"Transurethral insert for urinary occlusion/control in women with urinary incontinence"},{"c":"OCL","n":"Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue","k":"2","r":"878.4400","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":54,"b":0,"e":17,"d":"Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue"},{"c":"OCM","n":"Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"Surgical cardiac ablation for the treatment of atrial fibrillation."},{"c":"OCN","n":"Insulin Autoantibody Kit","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy."},{"c":"OCO","n":"Mouthguard, Migraine/Tension Headache","k":"U","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":3,"b":0,"e":0,"d":"A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity."},{"c":"OCQ","n":"Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence","k":"2","r":"884.1720","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For female urinary stress incontinence due to hypermobility"},{"c":"OCR","n":"Lung Sound Monitor","k":"2","r":"870.1875","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":0,"d":"The lung sound monitor is intended for use in monitoring and recording lung sounds."},{"c":"OCS","n":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"To allow for visualization of body cavities through an endoscope by projecting images to a monitor."},{"c":"OCT","n":"Anti Fog Solution And Accessories, Endoscopy","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":27,"b":0,"e":2,"d":"To prevent, reduce or eliminate condensation (fog) on endoscopic lens."},{"c":"OCU","n":"Endoscopic Storage Cover","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":1,"d":"To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization."},{"c":"OCV","n":"Endoscope Holder","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"To hold endoscope in a desired position during procedures."},{"c":"OCW","n":"Endoscopic Tissue Approximation Device","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":71,"b":0,"e":4,"d":"To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue."},{"c":"OCX","n":"Endoscopic Irrigation/Suction System","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":93,"b":0,"e":18,"d":"To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures."},{"c":"OCY","n":"Endoscopic Guidewire, Gastroenterology-Urology","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":43,"b":0,"e":10,"d":"To provide access to gi or gu tract for the purpose of passing or exchanging other accessories."},{"c":"OCZ","n":"Endoscopic Grasping/Cutting Instrument, Non-Powered","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":74,"b":0,"e":21,"d":"To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope."},{"c":"ODA","n":"Endoscopic Central Control Unit","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":18,"b":0,"e":0,"d":"To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command."},{"c":"ODB","n":"Endoscopic Contamination Prevention Sheath","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"To protect an endoscope from contamination by providing a barrier between the body and the endoscope."},{"c":"ODC","n":"Endoscope Channel Accessory","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":72,"b":0,"e":3,"d":"To give the endoscope channel additional or improved functionality."},{"c":"ODD","n":"Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":18,"b":0,"e":0,"d":"To identify stones, tumors, or narrowing in the biliary tree."},{"c":"ODE","n":"Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":20,"b":0,"e":4,"d":"To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant."},{"c":"ODF","n":"Mini Endoscope, Gastroenterology-Urology","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"ODG","n":"Endoscopic Ultrasound System, Gastroenterology-Urology","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":44,"b":0,"e":14,"d":"To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"ODH","n":"Implantable Bladder-Evacuation Electrical Stimulation System","k":"F","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable."},{"c":"ODI","n":"Administration Set Docking Station","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set."},{"c":"ODK","n":"Refractive Corneal Implant","k":"F","r":"","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred."},{"c":"ODN","n":"Ultrafiltration-Controlled Nocturnal Dialysate Delivery System","k":"2","r":"876.5860","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system."},{"c":"ODP","n":"Intervertebral Fusion Device With Bone Graft, Cervical","k":"2","r":"888.3080","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":354,"b":0,"e":11,"d":"Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft."},{"c":"ODR","n":"Electrosurgical Patient Return Electrode","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient."},{"c":"ODS","n":"Wound Covering (Composite Cultured Skin)","k":"F","r":"","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Wound covering. Indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adjunct to standard autograft procedures (i.E., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.E., ?mitten? hand deformities)."},{"c":"ODT","n":"Tissue Adhesive, Aortic Aneurysmorrhaphy","k":"F","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For use as an adjunct in the surgical repair of thoracic aortic aneurysms."},{"c":"ODU","n":"Facial Implant","k":"2","r":"878.3500","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks."},{"c":"ODV","n":"Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System","k":"2","r":"864.7750","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity."},{"c":"ODW","n":"Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System","k":"2","r":"862.3360","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":1,"d":"An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product."},{"c":"ODX","n":"Autonomous Extracorporeal Blood Leak Detector/Alarm","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood."},{"c":"ODY","n":"Tunneled Catheter Remover","k":"2","r":"880.5970","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body."},{"c":"OEA","n":"Non-Surgical Gown","k":"1","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":18,"d":"A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material"},{"c":"OEB","n":"Lung Computed Tomography System, Computer-Aided Detection","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":20,"b":0,"e":0,"d":"To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR."},{"c":"OED","n":"Antimicrobial Blood Pressure Cuff","k":"2","r":"870.1120","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure."},{"c":"OEE","n":"Diagnostic Low Electric Field","k":"3","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation."},{"c":"OEG","n":"Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The device is intended as an aid in the diagnosis of bullous pemphigoid."},{"c":"OEH","n":"Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit","k":"2","r":"866.3280","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis."},{"c":"OEI","n":"Drainage Catheter With Antibiotic","k":"2","r":"878.4780","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump."},{"c":"OEJ","n":"Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia","k":"2","r":"876.4300","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia"},{"c":"OEK","n":"Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia","k":"2","r":"876.4300","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia"},{"c":"OEL","n":"Laser, Benign Prostatic Hyperplasia","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia"},{"c":"OEM","n":"Human Metapneumovirus (Hmpv) Rna Assay System","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections."},{"c":"OEO","n":"Automated Digital Image Manual Interpretation Microscope","k":"2","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer."},{"c":"OEP","n":"Influenza A Virus Subtype Differentiation Nucleic Acid Assay","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza."},{"c":"OEQ","n":"Angiography/Angioplasty Kit","k":"2","r":"870.1650","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":91,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OER","n":"Angioscopic Valvulotome Kit","k":"2","r":"870.1650","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OES","n":"Cardiac Catheterization Kit","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":95,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OET","n":"Cardioplegia Solution Administration Kit","k":"2","r":"870.4240","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OEU","n":"Cardiopulmonary Bypass Catheter Kit","k":"2","r":"870.4210","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":3,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OEV","n":"Cardiopulmonary Resuscitation Aid Kit","k":"2","r":"868.5915","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":36,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OEW","n":"Tracking, Soft Tissue, Intraoperative","k":"2","r":"882.4560","p":"SU","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia."},{"c":"OEX","n":"Cardiovascular Catheter Sheath Introducer Kit","k":"2","r":"870.1340","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OEZ","n":"Cardiovascular Procedure Kit","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":232,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFA","n":"Cardiovascular Surgical Instruments Tray","k":"1","r":"870.4500","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":21,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFB","n":"Catheter Guide Wire Kit","k":"2","r":"870.1330","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFC","n":"Catheter Introducer Kit","k":"2","r":"870.1340","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":1,"b":0,"e":4,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFD","n":"Catheter Introducer Kit","k":"2","r":"870.1340","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":7,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. The convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFE","n":"Central Venous Blood Pressure Kit","k":"2","r":"870.1140","p":"CV","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.","x":-1},{"c":"OFF","n":"Central Venous Catheter Tray","k":"2","r":"870.1140","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":51,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFG","n":"Ct Biopsy Tray","k":"2","r":"870.4075","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":26,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFH","n":"Digital Angiography Tray","k":"2","r":"870.1650","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFI","n":"Laser Blood Flow Kit","k":"2","r":"870.2120","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFJ","n":"Lead Introducer Kit","k":"2","r":"870.1340","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFK","n":"Percutaneous Atrial Catheter Kit","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFL","n":"Percutaneous Sheath Introducer Kit","k":"2","r":"870.1340","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":5,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFM","n":"Phlebotomy Blood Collection Kit","k":"2","r":"870.2750","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":3,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFN","n":"Winged Intravenous Catheterization Kit","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFO","n":"Airway Suction Kit","k":"1","r":"868.6810","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFP","n":"Anesthesia Breathing Circuit Kit (Adult & Pediatric)","k":"1","r":"868.5240","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":33,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFQ","n":"Anesthesia Kit","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":9,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFR","n":"Tracheobronchial Suction Catheter Kit","k":"1","r":"868.6810","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":7,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFS","n":"Tracheal Suction Set","k":"1","r":"868.6810","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFT","n":"Spinal Epidural Anesthesia Kit","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":40,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFU","n":"Spinal Anesthesia Kit","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":3,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFV","n":"Regional Anesthesia Kit","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFW","n":"Restorative Instrument And Component Tray","k":"2","r":"872.3690","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFX","n":"General Purpose Dental Tray","k":"1","r":"872.6640","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":21,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFY","n":"Dental Implant Surgical Tray","k":"1","r":"872.3980","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OFZ","n":"Blood Specimen Collection Kit (Excludes Hiv Testing)","k":"1","r":"868.1100","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OGA","n":"Brachial Plexus Anesthesia Kit","k":"2","r":"868.5140","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OGB","n":"Caudal Anesthesia Kit","k":"2","r":"868.5140","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OGC","n":"Continuous Brachial Plexus Block Tray","k":"2","r":"868.5150","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OGD","n":"Custom Anesthesia Tray","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":7,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGE","n":"Epidural Anesthesia Kit","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":34,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGF","n":"Glossopharyngeal Anesthesia Kit","k":"2","r":"868.5120","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGG","n":"Humidifier Nebulizer Kit","k":"2","r":"868.5450","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGH","n":"Laryngoscope Kit","k":"1","r":"868.5540","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":4,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGI","n":"Nasal Endotracheal Tube Holder Kit","k":"1","r":"868.5770","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGJ","n":"Nerve Block Tray","k":"2","r":"868.5140","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":46,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGK","n":"Orotracheal Intubation Guide Kit","k":"2","r":"868.1400","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGL","n":"Oxygen Administration Kit","k":"2","r":"868.5655","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OGO","n":"Intraocular Pressure Lowering Implant","k":"3","r":"","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":5,"e":4,"d":"An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment."},{"c":"OGP","n":"Cricothyrotomy Kit","k":"2","r":"868.5800","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OGQ","n":"Ear Irrigation Kit","k":"1","r":"880.6960","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OGR","n":"Ear, Nose, And Throat Surgical Tray","k":"1","r":"874.4420","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":77,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OGS","n":"Myringotomy Procedure Kit","k":"2","r":"874.3880","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OGT","n":"Oral Irrigation Kit","k":"1","r":"872.6510","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OGU","n":"Pierced Ear/Entry Cleaning Tray","k":"1","r":"874.4420","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"Contents typically includes: Ear piercing instrument, alcohol prep pads (pro code: LKB - unclassified), ear piercing studs. This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OGV","n":"Tracheostomy Cleaning Tray","k":"2","r":"868.5800","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OGW","n":"Tracheostomy Kit","k":"2","r":"868.5800","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OGZ","n":"Catheter, Intravascular, Plaque Morphology Evaluation","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":1,"d":"Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques."},{"c":"OHA","n":"Heart Valve, More Than Minimally Manipulated Allograft","k":"U","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"1","a":4,"b":0,"e":4,"d":"For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions."},{"c":"OHC","n":"Obstetrical Vacuum Delivery Kit","k":"2","r":"884.4340","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHD","n":"Gynecological Laparoscopic Kit","k":"2","r":"884.1720","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":56,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHE","n":"Forensic Evidence Sexual Assault Kit","k":"2","r":"884.1630","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHF","n":"Culdocentesis Kit","k":"2","r":"884.1640","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHG","n":"Circumcision Tray","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":20,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHH","n":"Breast Pump Kit","k":"2","r":"884.5160","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHI","n":"Orthosis, Foot Drop","k":"1","r":"890.3475","p":"PM","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis.","x":36},{"c":"OHL","n":"Pap Smear Kit","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHM","n":"Cesarean Section Tray","k":"2","r":"884.1720","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":75,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHO","n":"First Aid Kit Without Drug","k":"1","r":"878.4014","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHP","n":"Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea","k":"2","r":"872.5570","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":2,"d":"Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea."},{"c":"OHQ","n":"Multi-Analyte Controls Unassayed","k":"1","r":"862.1660","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":27,"d":"A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls."},{"c":"OHR","n":"Catheter Care Tray","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":16,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OHS","n":"Light Based Over The Counter Wrinkle Reduction","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":165,"b":0,"e":4,"d":"Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided."},{"c":"OHT","n":"Light Based Over-The-Counter Hair Removal","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":167,"b":0,"e":0,"d":"Over-the-counter device uses thermal energy to kill hair follicles for hair removal."},{"c":"OHV","n":"Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption","k":"2","r":"878.4590","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":30,"b":0,"e":1,"d":"A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use."},{"c":"OHW","n":"Burr, Corneal, Battery Powered, Rust Ring Removal","k":"1","r":"886.4070","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal."},{"c":"OHX","n":"Burr, Corneal, Ac-Powered, Rust Ring Removal","k":"1","r":"886.4070","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal."},{"c":"OHY","n":"Pill Crusher/Cutter","k":"1","r":"880.6430","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting."},{"c":"OHZ","n":"Urine Transport Kit (Excludes Hiv Testing)","k":"1","r":"864.3250","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIA","n":"Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)","k":"1","r":"864.3250","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIB","n":"Blood And Urine Collection Kit (Excludes Hiv Testing)","k":"1","r":"864.3250","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":29,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIC","n":"Blood Alcohol Kit (Excludes Hiv Testing)","k":"2","r":"862.3040","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OID","n":"Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)","k":"1","r":"866.2900","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIE","n":"Urine Collection Kit (Excludes Hiv Testing)","k":"1","r":"864.3250","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIF","n":"Tyrosine Phosphatase (Ia-2) Autoantibody Assay","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes)."},{"c":"OIG","n":"Powder-Free Guayle Rubber Examination Glove","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"A disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."},{"c":"OIH","n":"Yersinia Spp. Reagents","k":"U","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":1,"b":0,"e":0,"d":"Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens. They are indicated for use as an aid in the laboratory of diagnosis of plague."},{"c":"OII","n":"Arthrogram Tray","k":"2","r":"892.1650","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":9,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIJ","n":"Biopsy Needle Guide Kit","k":"2","r":"892.1560","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":2,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIK","n":"Radiology Dental Tray","k":"2","r":"892.1650","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIL","n":"Discography Kit","k":"2","r":"892.1730","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIM","n":"Mri Disposable Kit","k":"2","r":"892.1000","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIN","n":"Prostate Seeding Kit","k":"2","r":"892.5730","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIO","n":"Radiographic Contrast Tray","k":"2","r":"892.1680","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIP","n":"Radiology-Diagnostic Kit","k":"2","r":"892.1680","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":5,"d":"FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OIR","n":"Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator","k":"3","r":"","p":"AN","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":2,"d":"The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older."},{"c":"OIS","n":"Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation","k":"2","r":"888.3045","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":1,"e":1,"d":"To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation."},{"c":"OIU","n":"Test, Epithelial Ovarian Tumor Associated Antigen (He4)","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients."},{"c":"OIV","n":"Dental Amalgam","k":"2","r":"872.3070","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth"},{"c":"OIW","n":"Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types","k":"2","r":"862.3100","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"This test is intended to measure the degree of similarity between the RNA expression pattern in a patient?s fresh-frozen tumor and the RNA expression patterns in a database of tumor samples for some common malignant tumor types that were diagnosed according to then current clinical and pathological practice. The test result is intended for use in the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified clinician. The test is not intended to establish the origin of tumors (e.g. carcinoma of unknown primary) that cannot be diagnosed according to current clinical and pathological practice."},{"c":"OIY","n":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive","k":"2","r":"888.3560","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":6,"d":"Indicated for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented use."},{"c":"OIZ","n":"Foot Examination Tool For Inflammatory Changes","k":"1","r":"890.5050","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. The device will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. Intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state."},{"c":"OJA","n":"Intravenous Extension Tubing Set","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":1,"b":0,"e":4,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJB","n":"Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate","k":"2","r":"888.3060","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation."},{"c":"OJE","n":"Right Ventricular Bypass (Assist) Device","k":"F","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure."},{"c":"OJF","n":"Hysterectomy Kit","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":30,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJG","n":"Neurological Tray","k":"1","r":"882.4525","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":94,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJH","n":"Orthopedic Tray","k":"1","r":"878.4800","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":239,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJI","n":"Burn Kit With Drug","k":"N","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"6","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJJ","n":"Burn Kit Without Drug","k":"1","r":"878.4022","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":7,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJK","n":"Eye Tray","k":"2","r":"886.4790","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":74,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJL","n":"Insulin Vial Protector/Holder","k":"1","r":"890.5050","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The device is intended to protect an insulin vial or vials"},{"c":"OJM","n":"Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh","k":"2","r":"888.3060","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation."},{"c":"OJN","n":"Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test","k":"3","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":5,"d":"For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations."},{"c":"OJO","n":"Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Enzyme linked immunosorbent assay (elisa) system intended for in vitro diagnostic use to qualitatively detect the presence of lipoarabinomannan (lam) antigen of mycobacteria in human urine as an aid in the diagnosis of current mycobacterial infection in hiv positive patients with systems of tuberculosis."},{"c":"OJP","n":"Orthopedic Computer Controlled Surgical System","k":"2","r":"882.4560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA)."},{"c":"OJQ","n":"Cardiac Allograft Gene Expression Profiling Test System","k":"2","r":"862.1163","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment."},{"c":"OJR","n":"Vacuum Powered Body Fluid Collection Kit","k":"2","r":"878.4780","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJS","n":"Tourniquet Kit","k":"1","r":"878.5900","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OJT","n":"Aspiration Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OJU","n":"Skin Prep Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":1,"b":0,"e":21,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OJV","n":"Single Use Instrument Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":38,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OJW","n":"Shave Prep Kit","k":"2","r":"878.4370","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OJX","n":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":7,"e":0,"d":"Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart."},{"c":"OJY","n":"Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers","k":"2","r":"866.3236","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A device to detect or measure nucleic acid from viruses associated with head and neck cancers is an in vitro diagnostic test for prescription use in the detection of viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer. The test result is intended to be used in conjunction with other clinical information to aid in assessing the clinical status of virus-associated head and neck cancers and/or the likelihood that head and neck cancer is present."},{"c":"OJZ","n":"Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde","k":"F","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":1,"d":"Device type: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest. Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics. Revision spine surgery to treat pseudarthrosis."},{"c":"OKC","n":"Implanted Subcutaneous Securement Catheter","k":"2","r":"880.5970","p":"HO","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site."},{"c":"OKD","n":"Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion","k":"F","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics."},{"c":"OKE","n":"Port Introducer Kit","k":"2","r":"880.5965","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":11,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKF","n":"Body Fluid Disposal Kit","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKG","n":"Body Fluid Clean Up Kit","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":3,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKH","n":"Body Fluids Barrier Kit","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKI","n":"Emergency Response Safety Kit","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":6,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKJ","n":"Light Based Treatment For Cold Sores Herpes Simplex Virus-1","k":"2","r":"878.4860","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization."},{"c":"OKL","n":"Intravascular Administration Set, Automated Air Removal System","k":"2","r":"880.5445","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid."},{"c":"OKM","n":"Antibodies, Outer-Membrane Proteins","k":"2","r":"866.5785","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease."},{"c":"OKN","n":"Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"To heat the bladder wall concomitant with intravesical instillation of a chemotherapy drug. For the prophylactic treatment of bladder cancer recurrence following standard resection of tumors."},{"c":"OKO","n":"Negative Pressure Wound Therapy Non-Powered Suction Apparatus","k":"2","r":"878.4683","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":18,"b":0,"e":0,"d":"A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials."},{"c":"OKP","n":"Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache","k":"2","r":"882.5808","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache."},{"c":"OKR","n":"Ventricular Bypass (Assist) Device","k":"3","r":"870.3545","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body."},{"c":"OKS","n":"Lacrimal Stents And Intubation Sets","k":"U","r":"","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"1","a":31,"b":0,"e":0,"d":"Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant."},{"c":"OKU","n":"Emergency Obstetrical Kit","k":"1","r":"884.4520","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OKV","n":"Obstetrical Kit","k":"2","r":"884.4520","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":95,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OKW","n":"Seminal Fluid Collection Kit","k":"2","r":"884.5300","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance"},{"c":"OKX","n":"Trocar Kit","k":"2","r":"884.1720","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKY","n":"Cytology Kit","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OKZ","n":"Endometrial Sampling Kit","k":"2","r":"884.1175","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OLC","n":"Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen","k":"2","r":"878.3300","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure."},{"c":"OLD","n":"Internal  Polymerase Chain Reaction  Control, Not Assay Specific","k":"1","r":"862.1660","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes."},{"c":"OLF","n":"Medevac Use Oxygen Generator","k":"2","r":"868.5440","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW."},{"c":"OLH","n":"Orchidometer","k":"1","r":"876.4730","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To measure testicular volume to diagnose abnormalities, or to determine the size of testicular prosthesis to implant."},{"c":"OLI","n":"Fat Reducing Low Level Laser","k":"2","r":"878.5400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":33,"b":0,"e":3,"d":"Non-invasive reduction in fat layer for body contouring"},{"c":"OLK","n":"Pulse Oximeter For Over-The-Counter Use","k":"2","r":"870.2700","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring"},{"c":"OLL","n":"Septal Stapler/Absorbable Staples","k":"2","r":"878.4750","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction."},{"c":"OLM","n":"Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)","k":"F","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"The device is indicated for bilateral stimulation of the anterior limb of the internal capsule, this device is indicated as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant Obsessive Compulsive Disorder (OCD) in adult patients who have failed at least three Selective Serotonin Reuptake Inhibitors (SSRIs)."},{"c":"OLO","n":"Orthopedic Stereotaxic Instrument","k":"2","r":"882.4560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":444,"b":0,"e":115,"d":"Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW."},{"c":"OLP","n":"Over-The-Counter Powered Light Based Laser For Acne","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":51,"b":0,"e":4,"d":"The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris."},{"c":"OLQ","n":"Cross-Sectional Mammographic Xray System","k":"3","r":"","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Diagnostic breast imaging. Imaging of the breast by cross-sectional x-ray imaging for diagnostic purposes."},{"c":"OLR","n":"Oral Wound Dressing","k":"U","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":43,"b":0,"e":1,"d":"Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ."},{"c":"OLS","n":"Oral Wound Dressing W/Drug And/Or Biologic","k":"U","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":0,"b":0,"e":0,"d":"Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per se to mgq."},{"c":"OLT","n":"Non-Normalizing Quantitative Electroencephalograph Software","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":57,"b":0,"e":0,"d":"Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user."},{"c":"OLU","n":"Normalizing Quantitative Electroencephalograph Software","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":0,"d":"Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user."},{"c":"OLV","n":"Standard Polysomnograph With Electroencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":65,"b":0,"e":1,"d":"Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data."},{"c":"OLW","n":"Index-Generating Electroencephalograph Software","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":40,"b":0,"e":1,"d":"Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user."},{"c":"OLX","n":"Source Localization Software For Electroencephalograph Or Magnetoencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":25,"b":0,"e":0,"d":"Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization"},{"c":"OLY","n":"Magnetoencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy."},{"c":"OLZ","n":"Automatic Event Detection Software For Polysomnograph With Electroencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":38,"b":0,"e":0,"d":"Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user"},{"c":"OMA","n":"Amplitude-Integrated Electroencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":16,"b":0,"e":3,"d":"Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner)."},{"c":"OMB","n":"Automatic Event Detection Software For Full-Montage Electroencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":42,"b":0,"e":1,"d":"Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user"},{"c":"OMC","n":"Reduced- Montage Standard Electroencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":29,"b":0,"e":0,"d":"Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes"},{"c":"OMD","n":"Cutaneous Tissue Adhesive With Mesh","k":"2","r":"878.4011","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures."},{"c":"OME","n":"Extracorporeal Shock Wave Treatment","k":"3","r":"","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"For use for extracorporeal shock wave treatment of atrophic nonunion fractures. The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal."},{"c":"OMF","n":"Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position","k":"2","r":"880.5970","p":"HO","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure."},{"c":"OMG","n":"Antisera, Fluorescent, Human Metapneumovirus","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV."},{"c":"OMH","n":"Pericardial Patch To Facilitate Revision Surgeries","k":"2","r":"870.3470","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery."},{"c":"OMI","n":"Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv","k":"2","r":"866.3510","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors."},{"c":"OMJ","n":"Chest X-Ray Computer Aided Detection","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review."},{"c":"OMM","n":"Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr","k":"2","r":"864.7280","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"In vitro diagnostic for the detection and genotyping of a single point mutation of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia."},{"c":"OMN","n":"C. Difficile Nucleic Acid Amplification Test Assay","k":"1","r":"866.2660","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":5,"b":0,"e":2,"d":"In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients."},{"c":"OMP","n":"Negative Pressure Wound Therapy Powered Suction Pump","k":"2","r":"878.4780","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":217,"b":0,"e":47,"d":"For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts."},{"c":"OMR","n":"Vessel Guard Or Cover","k":"2","r":"870.3470","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels."},{"c":"OMS","n":"Novel Influenza A Virus, A/H5 Ns1 Protein","k":"2","r":"866.3332","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza."},{"c":"OMT","n":"Absorbable Lung Biopsy Plug","k":"2","r":"878.4755","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed."},{"c":"OMV","n":"Ultrasonic Body Composition Analyzer","k":"2","r":"870.2770","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively."},{"c":"OMW","n":"Adhesive Backed Thermal Skin Patches","k":"1","r":"890.5710","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns."},{"c":"OMX","n":"High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis","k":"F","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage."},{"c":"OMZ","n":"Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention."},{"c":"ONA","n":"Computer Assisted Hair Harvesting System","k":"2","r":"882.4560","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":4,"d":"A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation."},{"c":"ONB","n":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":41,"b":0,"e":73,"d":"Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting."},{"c":"OND","n":"Osmolality Of Tears","k":"1","r":"862.1540","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation."},{"c":"ONE","n":"Powered Light Based Non-Laser Surgical Instrument","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light."},{"c":"ONF","n":"Powered Light Based Non-Laser Surgical Instrument With Thermal Effect","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":74,"b":0,"e":0,"d":"A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light."},{"c":"ONG","n":"Powered Laser Surgical Instrument With MicrobeamFractional Output","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":35,"b":0,"e":4,"d":"A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light."},{"c":"ONJ","n":"Dissolvable Gel For Preventing Ureteral Stone Migration","k":"2","r":"876.4680","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures."},{"c":"ONK","n":"Oral Lubricant","k":"1","r":"880.6375","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures."},{"c":"ONL","n":"Conformal Brachytherapy Source","k":"2","r":"892.5730","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device."},{"c":"ONM","n":"Radiant Infant Warmer Cabinet","k":"2","r":"880.5130","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer."},{"c":"ONN","n":"Intraoperative Orthopedic Joint Assessment Aid","k":"2","r":"882.4560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":18,"b":0,"e":8,"d":"Measurement and interpretation of orthopedic joint information."},{"c":"ONO","n":"Neurosurgical Laser With Mr Thermography","k":"2","r":"878.4810","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":1,"d":"Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery."},{"c":"ONQ","n":"Electrosurgical Coagulation For Aesthetic","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"For the treatment of spider vein or telangiectasia by thermocoagulation."},{"c":"ONT","n":"N95 Respirator With Antimicrobial/Antiviral Agent","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions."},{"c":"ONU","n":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":6,"e":1,"d":"A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral."},{"c":"ONV","n":"Electrical Impedance Spectrometer","k":"2","r":"878.1820","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":1,"e":0,"d":"An electrical impedance spectrometer is a prescription device that measures and analyzes electrical impedance properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma."},{"c":"ONW","n":"Hemodialysis System For Home Use","k":"2","r":"876.5860","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":4,"d":"To treat and provide hemodialysis therapy at home for chronic renal failure patients."},{"c":"ONX","n":"Ovarian Adnexal Mass Assessment Score Test System","k":"2","r":"866.6050","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources."},{"c":"ONY","n":"Oral Removable Retainer For Weight Management","k":"2","r":"876.5981","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A removable oral device used during meals to limit food intake."},{"c":"ONZ","n":"Mechanical Ventilator","k":"2","r":"868.5895","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,"},{"c":"OOA","n":"Hemorrhoid Prevention Pressure Wedge","k":"2","r":"884.5200","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery."},{"c":"OOB","n":"Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"A drug-eluting percutaneous transluminal coronary angioplasty catheter is a combination product intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A drug-eluting ptca catheter may also be intended for the treatment of acute myocardial infarction; Treatment of in-stent restenosis (isr) and/or post-deployment stent expansion. A drug-eluting ptca catheter delivers a drug to the vessel as part of the angioplasty procedure, which is intended to inhibit restenosis."},{"c":"OOD","n":"Surgical Film","k":"2","r":"878.3300","p":"SU","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":1,"d":"To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera."},{"c":"OOE","n":"Ophthalmic Femtosecond Laser","k":"2","r":"886.4390","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":47,"b":0,"e":8,"d":"Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery."},{"c":"OOF","n":"Cryogenic Cord Blood Storage Container","k":"2","r":"864.9900","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended as a final container for the cryopreservation and the storage of cord blood products. A cryogenic cord blood storage container is a flexible ethylene vinyl acetate (eva) or similar polymer bag intended as a final container for cryopreservation and storage of cord blood products in the liquid or vapor phases of liquid nitrogen."},{"c":"OOG","n":"Knee Arthroplasty Implantation System","k":"2","r":"888.3560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":3,"d":"Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components."},{"c":"OOI","n":"Real Time Nucleic Acid Amplification System","k":"2","r":"862.2570","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":14,"b":0,"e":30,"d":"The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system."},{"c":"OOK","n":"Dermal Cooling Pack/Vacuum/Massager","k":"2","r":"878.4340","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":14,"b":0,"e":6,"d":"The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas."},{"c":"OOL","n":"Electronic Depth Gauge","k":"2","r":"888.3030","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures."},{"c":"OOU","n":"Parainfluenza Multiplex Nucleic Acid Assay","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings."},{"c":"OOW","n":"Applicator For Rectal Suppository","k":"1","r":"876.4730","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended for use in the insertion of suppositories into the rectum"},{"c":"OOX","n":"Automated Occult Blood Analyzer","k":"2","r":"864.6550","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding."},{"c":"OOY","n":"Bronchial Thermoplasty System","k":"3","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways."},{"c":"OPC","n":"Powder-Free Polychloroprene Patient Examination Glove","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."},{"c":"OPH","n":"Radiation Attenuating Medical Glove","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Radiations attenuating medical gloves are medical gloves that are used during medical or surgical procedures involving radiation to shield the hands of the wearer from scattered radiation exposure. The gloves offer some degree of protection to the hand from radiation exposure as well as protection from transmission of infectious agents. The use of these gloves includes procedures that require the use of fluoroscopy or radiography. In addition to meeting the requirements for examination or surgeon¿s gloves, manufacturers should have technical data to show that their attenuation claims meet the energy range of x-rays normally used in medical procedures."},{"c":"OPJ","n":"Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs."},{"c":"OPL","n":"Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus","k":"2","r":"866.3510","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors."},{"c":"OPM","n":"Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2","k":"2","r":"866.3510","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors."},{"c":"OPN","n":"Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases"},{"c":"OPP","n":"Pump, Infusion, Insulin Bolus","k":"2","r":"880.5725","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus."},{"c":"OPR","n":"Intrasaccular Flow Disruption Device","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach."},{"c":"OPT","n":"Infrared Hematoma Detector","k":"2","r":"882.1935","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas."},{"c":"OPX","n":"Immunoglobulin A Kappa Heavy & Light Chain Combined","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients."},{"c":"OPY","n":"Igal Heavy & Light Chain Combined","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for the in-vitro quantification of iga lambda concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients."},{"c":"OQB","n":"Intervertebral Body Graft Containment Device","k":"2","r":"888.3085","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion."},{"c":"OQG","n":"Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented","k":"2","r":"888.3358","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":20,"b":0,"e":2,"d":"1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use."},{"c":"OQH","n":"Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented","k":"2","r":"888.3350","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use."},{"c":"OQI","n":"Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented","k":"2","r":"888.3353","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":4,"d":"1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use."},{"c":"OQL","n":"Mesh, Surgical, Deployment Balloon","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias."},{"c":"OQO","n":"Herpes Simplex Virus Nucleic Acid Amplification Assay","k":"2","r":"866.3305","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":1,"d":"A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens."},{"c":"OQQ","n":"Diagnostic Ultrasonic Transducer, Robotic","k":"2","r":"892.1570","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Diagnostic ultrasonic imaging or monitoring."},{"c":"OQS","n":"Laboratory Developed Test","k":"N","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Laboratory Developed Test"},{"c":"OQT","n":"Prostate Lesion, Documentation, System","k":"2","r":"876.2050","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination."},{"c":"OQU","n":"Airway Monitoring System","k":"2","r":"868.5730","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":6,"d":"The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip"},{"c":"OQW","n":"2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification","k":"2","r":"866.3332","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens"},{"c":"OQX","n":"Self-Contained Blood Grouping","k":"2","r":"864.9175","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":1,"d":"Intended for single use for individual blood group determination for educational and informational purposes"},{"c":"OQY","n":"Intrauterine Tamponade Balloon","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":11,"b":0,"e":2,"d":"provides temporary control or reduction of postpartum uterine bleeding"},{"c":"OQZ","n":"Anti-Mutated Citrullinated Vimentin Igg","k":"2","r":"866.5775","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma."},{"c":"ORA","n":"Breast Milk-Alcohol Test System","k":"2","r":"862.3040","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":1,"d":"Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk."},{"c":"ORC","n":"Air Filter Portable Apparatus","k":"2","r":"878.5070","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures."},{"c":"ORD","n":"Optical Coherence Tomography, Intravascular Catheter","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures."},{"c":"ORG","n":"Platelet And Plasma Separator For Bone Graft Handling","k":"2","r":"864.9245","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics."},{"c":"ORH","n":"Lamotrigine Assay","k":"2","r":"862.3350","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers."},{"c":"ORI","n":"Levetiracetam Assay","k":"2","r":"862.3350","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For the quantitative determination of levetiracetam in human serum or plasma."},{"c":"ORK","n":"Laser Assisted Lipolysis","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended to be used for laser assisted lipolysis"},{"c":"ORL","n":"Whole Blood Pre-Treatment T-Cell Enrichment Reagent","k":"3","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C)."},{"c":"ORQ","n":"Mesh, Surgical, Deployer","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair)."},{"c":"ORR","n":"Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri","k":"2","r":"882.4560","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite."},{"c":"ORT","n":"Burst Suppression Detection Software For Electroencephalograph","k":"2","r":"882.1400","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Automatically mark or identify electroencephalograph waveforms for rhythmic patterns of burst suppression in order to aid in identification of such events and help in the review and annotation of prolonged EEG traces; software can also quantify simple characteristics of the burst suppression such as inter-burst interval or count; all output subject to verification by qualified user."},{"c":"ORW","n":"N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies","k":"2","r":"880.6260","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A single use, disposable, NIOSH-approved N95 respirator intended for use by the general public in public health medical emergencies to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions."},{"c":"ORY","n":"Tongue Suspension System","k":"2","r":"872.5570","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring."},{"c":"ORZ","n":"Eyelid Thermal Pulsation System","k":"2","r":"886.5200","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":3,"d":"Therapeutic application of heat and massage to the eyelids."},{"c":"OSD","n":"Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature","k":"2","r":"890.5670","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity"},{"c":"OSE","n":"Patient Specific Manual Navigation System","k":"2","r":"882.4560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for defining implant alignment relative to a patient's anatomy."},{"c":"OSF","n":"Patient Specific Manual Orthopedic Stereotaxic System","k":"2","r":"882.4560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy."},{"c":"OSG","n":"Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch","k":"2","r":"882.5894","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"Relief / Reduction of Mosquito Bite Itch"},{"c":"OSH","n":"Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":19,"b":0,"e":1,"d":"Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis."},{"c":"OSI","n":"Bariatric Bed","k":"2","r":"880.5100","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":4,"d":"A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width."},{"c":"OSK","n":"Anti-Glutamate Receptor (Type Nmda) Ifa","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. Used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings."},{"c":"OSL","n":"Control, Fecal Occult Blood","k":"2","r":"864.6550","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices."},{"c":"OSM","n":"Hearing Aid, Air-Conduction With Wireless Technology, Prescription","k":"2","r":"874.3305","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid."},{"c":"OSN","n":"Software For Diagnosis/Treatment","k":"2","r":"888.3030","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":2,"d":"Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions"},{"c":"OSP","n":"Uterine Electromyographic Monitor","k":"2","r":"884.2720","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":3,"d":"The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy."},{"c":"OSR","n":"Pacemaker/Icd/Crt Non-Implanted Components","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":10,"e":15,"d":"Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider."},{"c":"OSU","n":"Dengue Serological Reagents","k":"2","r":"866.3945","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings."},{"c":"OSV","n":"Insufflator, Endoscopic Vessel Harvesting","k":"2","r":"884.1730","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated."},{"c":"OSX","n":"Galectin-3 In Vitro Diagnostic Assay","k":"2","r":"862.1117","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure."},{"c":"OSZ","n":"Antimicrobial Keyboard","k":"2","r":"880.6600","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To reduce microbial populations"},{"c":"OTA","n":"Mass Spectrometer For Clinical Multiplex Test Systems","k":"2","r":"862.2570","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"A mass spectrometer for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature."},{"c":"OTD","n":"Endovascular Suturing System","k":"2","r":"870.3460","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"Provides fixation and sealing between and endovascular graft and the native artery."},{"c":"OTE","n":"Digital Breast Tomosynthesis","k":"3","r":"","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":4,"e":6,"d":"To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer."},{"c":"OTF","n":"Gabapentin Assay","k":"2","r":"862.3350","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin."},{"c":"OTG","n":"Non-Sars Coronavirus Multiplex Nucleic Acid Assay","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings."},{"c":"OTJ","n":"Laparoscopic Single Port Access Device","k":"2","r":"876.1500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":11,"b":0,"e":0,"d":"A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery."},{"c":"OTK","n":"Wound Drain Catheter System","k":"2","r":"878.4780","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures."},{"c":"OTL","n":"Femtosecond Laser System For Refractive Correction","k":"3","r":"","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea"},{"c":"OTM","n":"Mesh, Surgical, For Stress Urinary Incontinence, Male","k":"2","r":"878.3300","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":1,"d":"surgical treatment of male stress urinary incontinence post-prostatectomy"},{"c":"OTN","n":"Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator","k":"2","r":"878.3300","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":66,"b":0,"e":1,"d":"Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility"},{"c":"OTO","n":"Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed","k":"2","r":"878.3300","p":"OB","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":23,"b":0,"e":1,"d":"Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy."},{"c":"OTP","n":"Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed","k":"3","r":"884.5980","p":"OB","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":31,"b":0,"e":0,"d":"Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally"},{"c":"OTQ","n":"Research Use Only/Hematology Devices","k":"N","r":"","p":"HE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"For research use only and for products imported into the US only."},{"c":"OTR","n":"Research Use Only/Immunology Devices","k":"N","r":"","p":"IM","g":"Y","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"For research use only and for products imported into the US only."},{"c":"OTT","n":"Research Use Only/Microbiology","k":"N","r":"","p":"MI","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"For research use only and for products imported into the US only."},{"c":"OTU","n":"Research Use Only/Pathology","k":"N","r":"","p":"PA","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"For research use only and for products imported into the US only."},{"c":"OTV","n":"Research Use Only/Clinical Chemistry Devices","k":"N","r":"","p":"CH","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"For research use only and for products imported into the US only."},{"c":"OTW","n":"Research Use Only/Clinical Toxicology","k":"N","r":"","p":"TX","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"For research use only and for products imported into the US only."},{"c":"OTX","n":"Foot Wrap For Treating Restless Leg Syndrome Symptoms","k":"1","r":"890.5760","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system."},{"c":"OTZ","n":"Graft Insertion Instrument For Endothelial Keratoplasty","k":"1","r":"886.4300","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed."},{"c":"OUB","n":"Instrument For Treatment Of Hyperhidrosis","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"Soft-tissue coagulation"},{"c":"OUC","n":"Norovirus Serological Reagent","k":"2","r":"866.3395","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks."},{"c":"OUE","n":"Micro Total Analysis Instrument System","k":"2","r":"862.2570","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":2,"d":"A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system."},{"c":"OUF","n":"Everolimus Immunoassay","k":"2","r":"862.3840","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"To quantify everolimus in whole blood."},{"c":"OUG","n":"Medical Device Data System","k":"1","r":"880.6310","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":24,"d":"A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring."},{"c":"OUH","n":"Skin Resurfacing Rf Applicator","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"Skin resurfacing"},{"c":"OUJ","n":"High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist","k":"2","r":"892.1570","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"OUK","n":"Surgical Mask With Antimicrobial/Antiviral Agent","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions."},{"c":"OUL","n":"Thermocycler, Generic","k":"1","r":"862.2310","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A thermocycler is an automated laboratory apparatus intended to amplify specific segments of double stranded nucleic acids isolated from a clinical sample via the polymerase chain reaction process. The nucleic acid sequences are amplified in the presence of specific primers, buffers, and thermostable polymerases, by raising and lowering the thermal block temperature at specific rates using pre-programmed steps, based on the specifications of the test which is being run. It may integrate interchangeable blocks of different materials or to accommodate different well and tube formats."},{"c":"OUM","n":"Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation","k":"1","r":"886.1050","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Measurement of retinal adaptation (regeneration of the visual purple) and absolute visible sensitivity to light."},{"c":"OUO","n":"Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance","k":"2","r":"892.1200","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":15,"b":0,"e":9,"d":"Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction."},{"c":"OUP","n":"Powered Surgical Instrument For Improvement In The Appearance Of Cellulite","k":"2","r":"878.4790","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":1,"d":"Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite."},{"c":"OUR","n":"Sacroiliac Joint Fixation","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":133,"b":0,"e":2,"d":"sacroiliac joint fusion"},{"c":"OUS","n":"Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt","k":"1","r":"866.2050","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain."},{"c":"OUT","n":"Intracranial Aneurysm Flow Diverter","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":14,"d":"Treatment of wide-necked and larger or giant intracranial aneurysms."},{"c":"OUU","n":"Polymeric Neurovascular Embolization","k":"F","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Treatment of intracranial aneurysms"},{"c":"OUW","n":"Infant Positioner, Rx, Use In Highly Monitored Setting","k":"1","r":"880.5680","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring."},{"c":"OUY","n":"Trichomonas Vaginalis Nucleic Acid Amplification Test System","k":"2","r":"866.3860","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":4,"d":"In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients"},{"c":"OUZ","n":"Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids","k":"1","r":"866.3870","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Detection of Leishmania species in skin lesions."},{"c":"OVA","n":"Complete Gene Expression Profiling Accessory Reagents","k":"2","r":"862.2570","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes."},{"c":"OVB","n":"Hydrogel Spacer","k":"2","r":"892.5725","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":2,"d":"The perirectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. The perirectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time."},{"c":"OVC","n":"Headframe","k":"N","r":"","p":"NE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke."},{"c":"OVD","n":"Intervertebral Fusion Device With Integrated Fixation, Lumbar","k":"2","r":"888.3080","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":205,"b":0,"e":36,"d":"Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation."},{"c":"OVE","n":"Intervertebral Fusion Device With Integrated Fixation, Cervical","k":"2","r":"888.3080","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":169,"b":0,"e":12,"d":"Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation."},{"c":"OVF","n":"Assay, Direct, Nucleic Acid Amplification, Q Fever","k":"1","r":"866.3500","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens."},{"c":"OVG","n":"Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)","k":"F","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis."},{"c":"OVJ","n":"Pulse Generator, External Pacemaker, Dual Chamber","k":"2","r":"870.3600","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":1,"e":0,"d":"A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction."},{"c":"OVK","n":"Cytokeratin Fragments 21-1 Eia Kit","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer."},{"c":"OVL","n":"Hemodialyzer, High Cut-Off","k":"F","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma."},{"c":"OVN","n":"Suture Kit","k":"2","r":"878.4830","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":10,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OVO","n":"Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended as a primary joint replacement prosthesis in total hip arthroplasty."},{"c":"OVP","n":"Vibratory Counter-Stimulation","k":"2","r":"882.5895","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome."},{"c":"OVQ","n":"Chronic Lymphocytic Leukemia Fish Probe Kit","k":"2","r":"866.6040","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"The CLL FISH Probe Kit is intended to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology and other clinical information."},{"c":"OVR","n":"Kit, First Aid, Talking","k":"1","r":"878.4014","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient."},{"c":"OVX","n":"Water Immersion Labor Pool","k":"N","r":"","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Partial water immersion during labor in hospitals, birth centers and home."},{"c":"OVY","n":"Liquid Chemical Processing System","k":"2","r":"880.6887","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"The liquid chemical processing system is intended as a standard method for routine monitoring."},{"c":"OVZ","n":"Pin, Fixation, Resorbable, Hard Tissue","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications."},{"c":"OWB","n":"Interventional Fluoroscopic X-Ray System","k":"2","r":"892.1650","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":325,"b":0,"e":638,"d":"Interventional fluoroscopy"},{"c":"OWD","n":"Somatic Gene Mutation Detection System","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":19,"e":13,"d":"The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues."},{"c":"OWE","n":"Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement","k":"2","r":"864.1890","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":1,"e":0,"d":"Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs."},{"c":"OWF","n":"Immunohistochemical Assay, Helicobacter Pylori","k":"1","r":"866.3110","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use"},{"c":"OWI","n":"Bone Fixation Cerclage, Sublaminar","k":"2","r":"888.3010","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":37,"b":0,"e":2,"d":"Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion."},{"c":"OWK","n":"Early Growth Response 1 (Egr) Fish Probe Kit","k":"2","r":"866.6040","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients."},{"c":"OWL","n":"Peripheral Catheter Insertion Kit","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":17,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"OWM","n":"Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers","k":"2","r":"866.6040","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer."},{"c":"OWN","n":"Confocal Optical Imaging","k":"2","r":"876.1500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":63,"b":0,"e":4,"d":"Collection of light signals for visualization of cellular microstructures."},{"c":"OWO","n":"Drug-Eluting Sinus Stent","k":"3","r":"","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids."},{"c":"OWP","n":"Biological Sterilization Process Indicator With Recombinant-Dna Plasmid","k":"2","r":"880.2805","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization."},{"c":"OWQ","n":"Reprocessed Intravascular Ultrasound Catheter","k":"2","r":"870.1200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":31,"b":0,"e":10,"d":"For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology."},{"c":"OWR","n":"Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in facial plastic surgery."},{"c":"OWS","n":"Mesh, Surgical, Collagen, Plastics, Facial Implants","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in facial plastic surgery."},{"c":"OWT","n":"Mesh, Surgical, Absorbable, Abdominal Hernia","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":13,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during hernia repair."},{"c":"OWU","n":"Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair."},{"c":"OWV","n":"Mesh, Surgical, Collagen, Diaphragmatic Hernia","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair."},{"c":"OWW","n":"Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon","k":"2","r":"878.3300","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":3,"d":"For reinforcement of soft tissue where weakness exists during tendon repair procedures."},{"c":"OWX","n":"Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon","k":"2","r":"878.3300","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in tendon repair."},{"c":"OWY","n":"Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon","k":"2","r":"878.3300","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":14,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in tendon repair."},{"c":"OWZ","n":"Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during chest wall reconstruction."},{"c":"OXA","n":"Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during chest wall reconstruction."},{"c":"OXB","n":"Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during chest wall reconstruction."},{"c":"OXC","n":"Mesh, Surgical, Absorbable, Staple Line Reinforcement","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures."},{"c":"OXD","n":"Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures."},{"c":"OXE","n":"Mesh, Surgical, Collagen, Staple Line Reinforcement","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures."},{"c":"OXF","n":"Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery."},{"c":"OXG","n":"Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery."},{"c":"OXH","n":"Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery."},{"c":"OXI","n":"Mesh, Surgical, Absorbable, Large Abdominal Wall Defects","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in abdominal wall defects."},{"c":"OXJ","n":"Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in abdominal wall defects."},{"c":"OXK","n":"Mesh, Surgical, Collagen, Large Abdominal Wall Defects","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in abdominal wall defects."},{"c":"OXL","n":"Mesh, Surgical, Absorbable, Organ Support","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during organ support."},{"c":"OXM","n":"Mesh, Surgical, Absorbable, Fistula","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during the repair of fistulas."},{"c":"OXN","n":"Mesh, Surgical, Collagen, Fistula","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists during the repair of fistulas."},{"c":"OXO","n":"Image-Intensified Fluoroscopic X-Ray System, Mobile","k":"2","r":"892.1650","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":82,"b":0,"e":50,"d":"Fluoroscopy of the human body."},{"c":"OXP","n":"Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment","k":"2","r":"866.6010","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies."},{"c":"OXQ","n":"Dressing Change Tray","k":"1","r":"880.5075","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":69,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"OXR","n":"5-Fluorouracil Assay","k":"N","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Measures levels of a chemotherapy drug in the blood."},{"c":"OXT","n":"Percutaneous Surgical Set With Attachments","k":"2","r":"878.4805","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues."},{"c":"OXW","n":"Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy","k":"N","r":"","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina."},{"c":"OXZ","n":"Pediatric/Child Facemask","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision."},{"c":"OYA","n":"P2psa","k":"3","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)"},{"c":"OYB","n":"Kit, Rna Detection, Human Papillomavirus","k":"3","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"For the detection of human papillomavirus RNA to aid in assessing risk of cancer."},{"c":"OYC","n":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":34,"d":"The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor."},{"c":"OYD","n":"Optical Diagnostic Device For Melanoma Detection","k":"2","r":"878.1820","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":1,"e":1,"d":"An optical diagnostic device for melanoma detection is a prescription device that measures and analyzes optical properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis. Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma."},{"c":"OYE","n":"Flow Cytometric Reagents And Accessories.","k":"2","r":"864.5220","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":26,"d":"To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer."},{"c":"OYF","n":"Aspiration Therapy System","k":"3","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults"},{"c":"OYG","n":"St2 Assay","k":"2","r":"862.1117","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma."},{"c":"OYH","n":"Orthodontic Vibratory Accessory","k":"2","r":"872.5470","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement."},{"c":"OYI","n":"Non-Bronchoscopic Bronchoalveolar Lavage Catheter","k":"1","r":"868.6810","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation."},{"c":"OYJ","n":"Dna Specimen Collection, Saliva","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing."},{"c":"OYK","n":"Ankle Arthroplasty Implantation System","k":"2","r":"888.3110","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":2,"d":"Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing."},{"c":"OYL","n":"Tryptase Assay System","k":"2","r":"866.5760","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An in vitro diagnostic device intended as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings."},{"c":"OYM","n":"Prostrate Cancer Genes Nucleic Acid Amplification Test System","k":"3","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes."},{"c":"OYO","n":"Culture, Intravaginal, Assisted Reproduction","k":"2","r":"884.6165","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period."},{"c":"OYP","n":"Anti-Jcv Antibody Detection Assay","k":"2","r":"866.3336","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies."},{"c":"OYR","n":"Filler, Bone Void, Recombinant Platelet-Derived Growth Factor","k":"N","r":"","p":"OR","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"For use as an alternative to autograft in hindfoot and ankle fusion procedures that require supplemental graft material, including tibiotalar, tibiocalcaneal, talonavicular and calcaneocuboid fusions."},{"c":"OYS","n":"Patient Bed With Canopy/Restraints","k":"1","r":"880.6760","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":1,"d":"Enclosed bed canopy system used as passive restraint."},{"c":"OYU","n":"Dna-Probe Kit, Human Chromosome","k":"2","r":"866.4700","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen."},{"c":"OYV","n":"Inherited Nucleotide Repeat Disorder Dna Test","k":"2","r":"866.5970","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening."},{"c":"OYW","n":"Laser, Cellulite Appearance","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For the removal of fat through laser lipolysis."},{"c":"OYX","n":"Bcr/Abl1 Monitoring Test","k":"2","r":"866.6060","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":3,"d":"A BCR/ABL1 Monitoring Test is a quantitative in vitro diagnostic device used to monitor the BCR/ABL1 to ABL1 ratio by reverse-transcriptase quantitative polymerase chain reaction (RQ-PCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients expressing BCR-ABL1 fusion transcripts such as e13a2 and/or e14a2. It is intended for use during monitoring of treatment response by reporting results on the international scale (%IS) and as log molecular reduction (MR) value."},{"c":"OYY","n":"Leukemia Translocation Panel Multiplex Test","k":"N","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The leukemia translocation panel multiplex test is a qualitative in vitro diagnostic device intended to identify specific fusion transcripts by reverse-transcriptase polymerase chain reaction (rt-pcr) from whole blood or bone marrow. It is intended for use as an aid in the diagnosis of recurrent balanced or reciprocal translocation positive acute and chronic myeloid leukemia, acute lymphocytic or promyelocytic leukemias."},{"c":"OYZ","n":"Group A Streptococcus Nucleic Acid Amplification Assay System","k":"1","r":"866.3740","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients."},{"c":"OZA","n":"Test, Urea Adult And Pediatric (Breath),","k":"3","r":"866.3110","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy."},{"c":"OZB","n":"Dengue Nucleic Acid Amplification Assay (Naat)","k":"2","r":"866.3946","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe)."},{"c":"OZC","n":"Over The Counter Thermal Treatment For Acne.","k":"2","r":"890.5740","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the treatment of mild to moderate inflammatory acne."},{"c":"OZD","n":"Temporary Non-Roller Type Left Heart Support Blood Pump","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":50,"d":"A blood pump that provides temporary full or partial left heart support"},{"c":"OZE","n":"Influenza A And Influenza B Multiplex Nucleic Acid Assay","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":21,"b":0,"e":5,"d":"An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings."},{"c":"OZF","n":"Tissue Rna Preservative For Collection, Storage, And Transportation","k":"2","r":"866.4070","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing."},{"c":"OZG","n":"Transcatheter Septal Occluder (Atrial)","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique."},{"c":"OZH","n":"Transcatheter Septal Occluder (Ventricular)","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique."},{"c":"OZI","n":"Internal Hinged Elbow Fixator","k":"2","r":"888.3030","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved."},{"c":"OZJ","n":"Inhibitor, Postoperative Fibrosis (Adhesion Barrier)","k":"N","r":"","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions."},{"c":"OZK","n":"Thermometer, Exhaled Breath","k":"2","r":"880.2910","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To measure the temperature of exhaled human breath, which is frequently increased in airway inflammation in asthma patients. Measurement of changes in exhaled human breath temperature aids in evaluating airway inflammation treatment in asthma patients as an adjunct to established clinical and laboratory assessments of asthma."},{"c":"OZN","n":"C. Difficile Toxin Gene Amplification Assay","k":"2","r":"866.3130","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":18,"b":0,"e":8,"d":"Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients."},{"c":"OZO","n":"Automated Insulin Dosing , Threshold Suspend","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":11,"d":"An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels."},{"c":"OZP","n":"Automated Insulin Dosing Device System, Single Hormonal Control","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":23,"d":"An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels."},{"c":"OZQ","n":"Automated Insulin Dosing  Device System, Bihormonal Control","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels."},{"c":"OZR","n":"Intraoral Pressure Gradient Device","k":"2","r":"872.5570","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward. It is intended to be used while a patient is sleeping to treat obstructive sleep apnea."},{"c":"OZT","n":"Balloon Aortic Valvuloplasty","k":"2","r":"870.1255","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":22,"b":0,"e":2,"d":"A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve."},{"c":"OZW","n":"Ingestible Event Marker","k":"2","r":"880.6305","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device"},{"c":"OZX","n":"Mycoplasma Pneumoniae Dna Assay System","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection."},{"c":"OZY","n":"Chlamydophila Pneumoniae Dna Assay System","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection."},{"c":"OZZ","n":"Bordetella Pertussis Dna Assay System","k":"2","r":"866.3980","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":2,"d":"A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection."},{"c":"PAA","n":"Automated Breast Ultrasound","k":"3","r":"","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"Adjunct to mammography for breast cancer screening and diagnosis."},{"c":"PAB","n":"Cytomegalovirus (Cmv) Dna Quantitative Assay","k":"2","r":"866.3180","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":6,"e":1,"d":"Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings."},{"c":"PAD","n":"Chest Drainage Kit","k":"2","r":"880.6740","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":20,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.","x":-1},{"c":"PAE","n":"Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography","k":"2","r":"890.3450","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality."},{"c":"PAF","n":"Voltage Gated  Calcium Channel (Vgcc) Antibody Assay","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings."},{"c":"PAG","n":"Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator","k":"2","r":"878.3300","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility."},{"c":"PAH","n":"Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling","k":"2","r":"878.3300","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":20,"b":0,"e":1,"d":"Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility."},{"c":"PAI","n":"Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed","k":"3","r":"884.5980","p":"OB","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":2,"b":0,"e":0,"d":"Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally."},{"c":"PAJ","n":"Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed","k":"2","r":"878.3300","p":"OB","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy."},{"c":"PAL","n":"Pulmonic Replacement Heart Valve","k":"F","r":"870.3925","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For open surgical replacement of malfunctioning pulmonic heart valve."},{"c":"PAM","n":"Gram-Positive Bacteria And Their Resistance Markers","k":"2","r":"866.3365","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":11,"d":"A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures."},{"c":"PAN","n":"Braf Mutation Kit","k":"N","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The BRAF mutation kit is a multiplex qualitative in vitro diagnostic device to identify specific BRAF mutations by multiplex polymerase chain reaction of genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) colorectal cancer or fine needle aspirated (FNA) thyroid tissue. It is intended to aid in the treatment decisions and risk stratification of patients diagnosed with colorectal or papillary thyroid cancer."},{"c":"PAO","n":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented","k":"2","r":"888.3660","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":3,"d":"Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures."},{"c":"PAP","n":"Aortic Heart Valve, More Than Minimally Manipulated Allograft","k":"F","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients."},{"c":"PAQ","n":"Test, Nr2 Antibody","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage."},{"c":"PAR","n":"Test, Volatile Organic Compounds Breath Analysis","k":"F","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month."},{"c":"PAS","n":"Rf/Microwave Hyperthermia System, Cancer Treatment","k":"F","r":"","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Used in conjunction with radiation therapy for the treatment of cervical carcinoma patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors."},{"c":"PAT","n":"Bladder System","k":"F","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine."},{"c":"PAV","n":"Catheter, Neuro-Vasculature, Occluding Balloon","k":"F","r":"882.5150","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":1,"d":"Used to obstruct lower aortic blood flow to augment cerebral perfusion."},{"c":"PAW","n":"Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement","k":"2","r":"870.3470","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"To repair or replace chordae tendinae."},{"c":"PAX","n":"Surgical Kit","k":"F","r":"","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":2,"d":"For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity."},{"c":"PAY","n":"Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction","k":"2","r":"878.4420","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use."},{"c":"PAZ","n":"Electrical Stimulation  Bladder System","k":"F","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation."},{"c":"PBA","n":"Ecarin Clotting Time","k":"F","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"The TAS ECT Test Card is to be used with the TAS Analyzer and is intended to determine the anticoagulant effect of hirudin during CBP in patients who have HIT. It is suited for professional use in decentralized areas of testing near the site of patient care as well as for use in the more traditional laboratory. Monitoring with the TAS ECT is indicated for persons who have been identified with and/or confirmed as a high risk for HIT, and require high dose anticoagulant with hirudin for a scheduled or emergency CPB procedure."},{"c":"PBC","n":"Manual Blood Grouping And Antibody Test Systems","k":"2","r":"864.9175","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens."},{"c":"PBD","n":"Composite Cultured Skin","k":"F","r":"878.4024","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)"},{"c":"PBF","n":"Orthopaedic Surgical Planning And Instrument Guides","k":"2","r":"888.3030","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":27,"b":0,"e":0,"d":"As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures."},{"c":"PBH","n":"Embryo Image Assessment System, Assisted Reproduction","k":"2","r":"884.6195","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing ."},{"c":"PBI","n":"Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive","k":"2","r":"888.3310","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":2,"d":"For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered."},{"c":"PBJ","n":"Cranial Distraction System","k":"2","r":"882.5330","p":"NE","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments."},{"c":"PBK","n":"Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set","k":"2","r":"866.3315","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture."},{"c":"PBN","n":"Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients","k":"F","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Removal of plasma components to treat focal glomerulosclerosis"},{"c":"PBP","n":"Rectal Insert","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Acts as a barrier to the passage of fecal matter through the rectum."},{"c":"PBQ","n":"Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":1,"d":"Attaching suture or stapling ligaments of the pelvic floor."},{"c":"PBU","n":"Bone Void Filler, Syringe","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"To fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis)."},{"c":"PBX","n":"Massager, Vacuum, Radio Frequency Induced Heat","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":81,"b":0,"e":1,"d":"Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite."},{"c":"PBY","n":"Temporary Tissue Marker","k":"2","r":"878.4300","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue."},{"c":"PBZ","n":"Image Processing Device For Estimation Of External Blood Loss","k":"2","r":"880.2750","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":4,"d":"An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images."},{"c":"PCA","n":"Dna Genetic Analyzer","k":"2","r":"862.2570","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A genetic analyzer is an automated clinical multiplex instrument system intended to measure and sort signals generated by multiple fluorescent dyes in order to analyze DNA/RNA molecules in an assay from a clinical sample. Individual nucleotide sequences and DNA fragment sizes are identified using chain- or dye-termination or dye primer cycle sequencing, or PCR amplification with labeled primers, respectively. Labeled nucleotides and DNA fragments are separated by size and charge using a polymer-based separation matrix with capillary electrophoresis or other method. Fluorescence emissions are measured using filters on a photodiode or other detector and interpreted with software."},{"c":"PCB","n":"External Cerebrospinal Fluid (Csf) Diversion","k":"2","r":"882.5560","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":5,"d":"Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion."},{"c":"PCC","n":"Stimulator, Nerve, Electrical, Transcutaneous, For Migraine","k":"2","r":"882.5891","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":18,"b":0,"e":0,"d":"Used to apply an electrical current to a patient's cranium through electrodes placed on the skin."},{"c":"PCD","n":"Powered Stairway Chair Lift","k":"2","r":"890.5150","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":3,"d":"A powered patient stairway chair lift (Stair Machine) is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway"},{"c":"PCE","n":"Permanently Mounted Wheelchair Platform Lift","k":"2","r":"890.3930","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another."},{"c":"PCF","n":"Sampler, Endocervical","k":"2","r":"884.1050","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Obtains tissue samples from the endocervical canal for histological analysis."},{"c":"PCG","n":"21-Hydroxylase Antibody (21-Ohab)","k":"2","r":"866.5660","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency."},{"c":"PCH","n":"Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System","k":"2","r":"866.3990","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":38,"b":0,"e":24,"d":"A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings."},{"c":"PCI","n":"Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System","k":"2","r":"866.3990","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings."},{"c":"PCK","n":"Pediatric Ventricular Assist Device","k":"F","r":"870.3545","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body."},{"c":"PCL","n":"Enzyme Linked Immunoabsorbent Assay, Rubeola Igm","k":"1","r":"866.3520","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":3,"d":"The qualitative detection of measles specific IgM antibodies in serum or plasma."},{"c":"PCM","n":"Portable Liquid Oxygen Unit Stand","k":"1","r":"890.5050","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position."},{"c":"PCN","n":"Immunoglobulin G Kappa Heavy And Light Chain Combined","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Intended for the in-vitro quantification of IgG kappa concentration in human serum."},{"c":"PCO","n":"Immunoglobulin G Lambda Heavy And Light Chain Combined","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for the in-vitro quantification of IgG lambda concentration in human serum. The result is to be used with previously diagnosed IgG multiple myeloma, in conjunction with other clinical and laboratory findings."},{"c":"PCQ","n":"Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)","k":"N","r":"","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Intended for use as a mechanical barrier to adhesion formation."},{"c":"PCS","n":"Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox","k":"2","r":"892.1001","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver for any indication where an assessment of liver iron concentration is needed. For non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT patients for whom deferasirox therapy is being considered and for monitoring of NTDT patients receiving deferasirox therapy."},{"c":"PCT","n":"Prostate Immobilizer Rectal Balloon","k":"2","r":"892.5720","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":2,"d":"Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment."},{"c":"PCU","n":"Pancreatic Stent, Covered, Metallic, Removable","k":"2","r":"876.5015","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":11,"b":0,"e":6,"d":"To facilitate transmural endoscopic drainage of pancreatic pseudocysts"},{"c":"PCV","n":"Endoscopic Leak Tester","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope."},{"c":"PCW","n":"Implantable Pulse Generator, Programmer And Battery Charger","k":"N","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"intended for the treatment of moderate to severe heart failure."},{"c":"PCX","n":"Artificial Chordae Tendinae Delivery System","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Deploys ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair."},{"c":"PCY","n":"Investigational Use Only - Microbiology","k":"N","r":"","p":"MI","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Investigational use only and for products imported into the US only."},{"c":"PCZ","n":"Investigational Use Only - Immunology","k":"N","r":"","p":"HE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Investigational use only and for products imported into the US only."},{"c":"PDA","n":"Investigational Use Only - Clinical Chemistry","k":"N","r":"","p":"CH","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Investigational use only and for products imported into the US only."},{"c":"PDB","n":"Investigational Use Only - Clinical Toxicology","k":"N","r":"","p":"TX","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Investigational use only and for products imported into the US only."},{"c":"PDC","n":"Investigational Use Only - Hematology","k":"N","r":"","p":"HE","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Investigational use only and for products imported into the US only."},{"c":"PDD","n":"Investigational Use Only - Pathology","k":"N","r":"","p":"PA","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Investigational use only and for products imported into the US only."},{"c":"PDE","n":"Immunoglobulin M Kappa Heavy And Light Chain Combined","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings."},{"c":"PDF","n":"Immunoglobulin M Lambda Heavy And Light Chain Combined","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for the in-vitro quantification of IgM lambda concentration in human serum. The result is to be used with previously diagnosed IgM Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings."},{"c":"PDG","n":"Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed."},{"c":"PDH","n":"Blanket, Neonatal Phototherapy","k":"2","r":"880.5700","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting."},{"c":"PDI","n":"Beta 2-Microglobulin Apheresis Column","k":"F","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA)."},{"c":"PDJ","n":"Hemoglobin A1c Test System","k":"2","r":"862.1373","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":27,"b":0,"e":9,"d":"Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes."},{"c":"PDK","n":"Cream For X-Ray Attenuation","k":"2","r":"892.6510","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure."},{"c":"PDO","n":"Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization","k":"2","r":"864.1870","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist."},{"c":"PDQ","n":"Neurosurgical Nerve Locator","k":"2","r":"874.1820","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":36,"b":0,"e":2,"d":"To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery."},{"c":"PDR","n":"Computer-Assisted Personalized Sedation System","k":"3","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation."},{"c":"PDS","n":"Amniotic Fluid Protein Immunoassay","k":"1","r":"862.1550","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To detect specified amniotic fluid proteins in cervicovaginal samples"},{"c":"PDT","n":"Burn Resuscitation Decision Support Software","k":"2","r":"868.1890","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn."},{"c":"PDU","n":"Catheter For Crossing Total Occlusions","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":58,"b":0,"e":7,"d":"To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement."},{"c":"PDW","n":"Internal Tissue Marker","k":"2","r":"878.4670","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues."},{"c":"PDX","n":"Flow Cytometry Calibrator","k":"2","r":"864.5220","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers."},{"c":"PDY","n":"Organophosphate Test System","k":"2","r":"862.3652","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure."},{"c":"PDZ","n":"Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":19,"b":0,"e":1,"d":"For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.)."},{"c":"PEA","n":"Endoscope, Accessories, Image Post-Processing For Color Enhancement","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":5,"d":"Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement."},{"c":"PEB","n":"Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible","k":"2","r":"884.5300","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices."},{"c":"PEC","n":"Sterilizer Automated Loading System","k":"2","r":"880.6880","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer."},{"c":"PEF","n":"Heparin Flush In 0.45% Sodium Chloride","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The heparin flush in 0.45% sodium chloride is intended to maintain patency of an indwelling intravenous catheter device designed for intermittent injection or infusion therapy or blood sampling. It provides an alternative to clinicians to prevent sodium overload in neonatal patients."},{"c":"PEG","n":"Nucleic Acid Quantitation Kit","k":"1","r":"862.2310","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A nucleic acid quantitation kit consists of a nucleic acid stain (e.g., fluorescent, colorimetric, etc.) which is used to detect and quantitate small amounts of DNA, RNA, or oligonucleotides in solution by measuring the amount of fluorescence or absorbance at a specified wavelength."},{"c":"PEH","n":"Hemodialysis Catheter Luer End Cap","k":"2","r":"876.5540","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"For use in hemodialysis catheters to reduce hub infection."},{"c":"PEJ","n":"Salivary Estriol Test","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"To detect and measure salivary estriol in pregnant women."},{"c":"PEK","n":"Spinous Process Plate","k":"2","r":"888.3050","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":49,"b":0,"e":1,"d":"A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use."},{"c":"PEM","n":"Dental Barriers And Sleeves","k":"2","r":"878.4370","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":17,"b":0,"e":0,"d":"Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients."},{"c":"PEN","n":"Gram-Negative Bacteria And Associated Resistance Markers","k":"2","r":"866.3365","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":20,"d":"A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures."},{"c":"PEO","n":"Fungal Organisms, Nucleic Acid-Based Assay","k":"2","r":"866.3365","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures."},{"c":"PEP","n":"Molecular Erythrocyte Typing Test","k":"3","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":1,"d":"Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes"},{"c":"PEQ","n":"Accessories To Examination Light","k":"1","r":"880.6320","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed."},{"c":"PER","n":"Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis","k":"1","r":"862.2750","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":10,"d":"Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis."},{"c":"PET","n":"Anti-Ss-A Ro60 Autoantibodies","k":"2","r":"866.5100","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Ro60 assays are designed for the determination of IgG anti-Ro60 (SS-A Ro60) autoantibodies in human serum. The presence of anti-Ro60 autoantibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus and Sjögren's Syndrome."},{"c":"PEU","n":"System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen","k":"2","r":"866.3373","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings."},{"c":"PEV","n":"Dialysis Administration Kit","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":6,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"PEW","n":"Implantable Transprostatic Tissue Retractor System","k":"2","r":"876.5530","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":11,"b":0,"e":2,"d":"The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above."},{"c":"PEX","n":"System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates","k":"2","r":"866.3361","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":3,"d":"A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens."},{"c":"PEZ","n":"Central Venous Catheter Dressing Change Kit","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":4,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"PFA","n":"Non-Invasive Central Venous Manometer","k":"2","r":"870.1140","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology."},{"c":"PFC","n":"Cultured Human Cell Skin Dressing","k":"3","r":"","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers."},{"c":"PFE","n":"Gastrointestinal Liner System","k":"N","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months."},{"c":"PFF","n":"High Throughput Dna Sequence Analyzer","k":"2","r":"862.2265","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":18,"d":"A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample."},{"c":"PFG","n":"Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders","k":"2","r":"864.1870","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens."},{"c":"PFH","n":"Venous Window Needle Guide","k":"2","r":"876.5540","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion."},{"c":"PFJ","n":"Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor","k":"2","r":"884.4260","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"Mechanical dilation of the cervical canal for labor."},{"c":"PFK","n":"Quality Control For Molecular Immunohematology Tests","k":"2","r":"864.9650","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens."},{"c":"PFL","n":"Intraoral, Dental Foam Protector","k":"1","r":"872.6890","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to provide a soft barrier between wired mouth hardware and oral mucosa."},{"c":"PFM","n":"Hemibridge System","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Non-fusion growth modulation of spinal column."},{"c":"PFN","n":"Implanted Brain Stimulator For Epilepsy","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"For the treatment of epilepsy."},{"c":"PFO","n":"Active Implantable Bone Conduction Hearing System","k":"2","r":"874.3340","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone."},{"c":"PFP","n":"Silicone Hydrogel For Scar Management","k":"1","r":"878.4025","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Management of closed hyperproliferative (hypertrophic and keloid) scars."},{"c":"PFQ","n":"Mmp-9 Test System","k":"1","r":"862.1540","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":3,"d":"A visual, qualitative immunoassay for the in vitro detection of elevated levels of the MMP-9 protein in tear fluid from patients suspected of having dry eye."},{"c":"PFR","n":"System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection","k":"2","r":"866.5900","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening."},{"c":"PFS","n":"System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection","k":"2","r":"866.5900","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes"},{"c":"PFT","n":"Reagents For Molecular Diagnostic Test Systems","k":"1","r":"862.3800","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":2,"d":"A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems."},{"c":"PFU","n":"Tissue Processing Kit","k":"N","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"For the preparation of human tissue specimens for frozen sectioning and histological examination."},{"c":"PFV","n":"System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":5,"e":1,"d":"An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis."},{"c":"PFW","n":"Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat","k":"2","r":"890.5300","p":"PM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation."},{"c":"PFX","n":"System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection","k":"2","r":"866.5920","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":2,"d":"A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other clinical information currently used in postnatal diagnosis. It is not intended to be used for standalone diagnostic purposes, prenatal or pre-implantation testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations."},{"c":"PFY","n":"Low Patient Acuity Monitoring System","k":"2","r":"870.2300","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients."},{"c":"PFZ","n":"Ophthalmic Sealant","k":"3","r":"","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye."},{"c":"PGD","n":"Colon Capsule Imaging System","k":"2","r":"876.1330","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"visualization of the colon for the detection of polyps"},{"c":"PGE","n":"Gastric Emptying Breath Test","k":"3","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal."},{"c":"PGH","n":"Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel","k":"2","r":"866.3307","p":"MI","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions."},{"c":"PGI","n":"Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples","k":"2","r":"866.3309","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":2,"d":"For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid."},{"c":"PGJ","n":"Oximeter, Wellness","k":"2","r":"870.2700","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"Pulse oximeter intended for wellness use."},{"c":"PGK","n":"Cannula, Injector, Uterine, Endometrial Biopsy","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy"},{"c":"PGM","n":"Growing Rod System","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":14,"b":0,"e":0,"d":"Stabilization or correction of spinal deformities without the use of fusion."},{"c":"PGN","n":"Growing Rod System- Magnetic Actuation","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":4,"d":"Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod."},{"c":"PGO","n":"Anti-Stick Glass Syringe","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Single use devices that are indicated for use as an accessory with sterile 1ML long staked needle prefilled ISO standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject, doctor prescribed medications, and individuals that assist self-injecting patients from accidental needle sticks. Can be used on a wide range of patients including children and adults."},{"c":"PGQ","n":"Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification","k":"3","r":"","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":3,"d":"Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity."},{"c":"PGT","n":"Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar","k":"2","r":"884.1710","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue."},{"c":"PGU","n":"Spatial Imaging For Display Of Endoscope Position","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To detect and display the shape of an inserted endoscope."},{"c":"PGV","n":"Anti-Phospholipase A2 Receptor","k":"2","r":"866.5780","p":"IM","g":"N","l":"Y","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings."},{"c":"PGW","n":"Ear, Nose, And Throat Stereotaxic Instrument","k":"2","r":"882.4560","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":38,"b":0,"e":17,"d":"Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy."},{"c":"PGX","n":"Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System","k":"2","r":"866.2680","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":15,"b":0,"e":4,"d":"An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients."},{"c":"PGY","n":"Display, Diagnostic Radiology","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":138,"b":0,"e":6,"d":"The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners."},{"c":"PGZ","n":"Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use","k":"2","r":"878.4452","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"To control bleeding in junctional, non-compressible wounds until surgical care is acquired."},{"c":"PHC","n":"Infusion Safety Management Software","k":"2","r":"880.5725","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":13,"d":"Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission."},{"c":"PHF","n":"Zinc Transporter 8 Auto-Antibody","k":"2","r":"866.5670","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings."},{"c":"PHG","n":"Droplet Digital Pcr System","k":"2","r":"862.2570","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique. A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays which specify its use."},{"c":"PHJ","n":"System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations","k":"2","r":"864.7280","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia."},{"c":"PHK","n":"Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"6","u":"9","a":0,"b":0,"e":0,"d":"The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information."},{"c":"PHL","n":"Powered Exoskeleton","k":"2","r":"890.3480","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":26,"b":0,"e":3,"d":"A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes."},{"c":"PHM","n":"Intervertebral Fusion Device With Bone Graft, Thoracic","k":"2","r":"888.3080","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft."},{"c":"PHN","n":"Protective Coating, Mucoadhesive Application, For The Rectal Mucosa","k":"U","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"1","a":5,"b":0,"e":0,"d":"Mucoadhesive application for the protective coating of the rectal mucosa."},{"c":"PHO","n":"Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs","k":"3","r":"","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":1,"d":"Preservation of donor lungs for transplantation."},{"c":"PHP","n":"System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":5,"e":2,"d":"The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening."},{"c":"PHQ","n":"Anterior Staple As Supplemental Fixation For Fusion","k":"2","r":"888.3060","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Anterior cervical device for supplemental fixation to support a fusion."},{"c":"PHR","n":"Diammine Silver Fluoride Dental Hypersensitivity Varnish","k":"2","r":"872.3260","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity."},{"c":"PHS","n":"Oral Airway Assist","k":"1","r":"868.5110","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To assist in maintaining an open airway."},{"c":"PHT","n":"Basin For Endoscope Reprocessing","k":"1","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To allow endoscopes to soak in reprocessing solutions."},{"c":"PHU","n":"Intra-Abdominal Pressure Monitoring Device","k":"U","r":"","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"1","a":2,"b":0,"e":1,"d":"Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure."},{"c":"PHV","n":"Continuous Glucose Monitor Retrospective Data Analysis Software","k":"1","r":"862.2120","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":3,"d":"Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device."},{"c":"PHW","n":"Cold Pack And Vibrating Massager","k":"1","r":"890.5975","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture)."},{"c":"PHX","n":"Shoulder Prosthesis, Reverse Configuration","k":"2","r":"888.3660","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":207,"b":0,"e":69,"d":"Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint."},{"c":"PHY","n":"Sparse Sample Pk Profile And Dosing Software","k":"2","r":"868.1890","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To estimate PK profile and dosing calculation."},{"c":"PHZ","n":"Abnormal Breath Sound Device","k":"2","r":"868.1900","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling."},{"c":"PIA","n":"Vibrator For Climax Control Of Premature Ejaculation","k":"2","r":"876.5025","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Vibrator for climax control training for the treatment of premature ejaculation."},{"c":"PIB","n":"Diabetic Retinopathy Detection Device","k":"2","r":"886.1100","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions."},{"c":"PIC","n":"Oral Electronic Vision Aid","k":"2","r":"886.5905","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)"},{"c":"PID","n":"Esophageal Dilator Balloon With Or Without Electrode Sensors","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"To dilate the lower esophageal sphincter of patients with Achalasia."},{"c":"PIE","n":"Esophageal Dilator With Balloon And Electrode Sensors","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To dilate esophageal strictures with a dilating balloon and electrode sensors."},{"c":"PIF","n":"Gastrointestinal Tubes With Enteral Specific Connectors","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":52,"b":0,"e":112,"d":"To facilitate enteral specific connections."},{"c":"PIG","n":"Acute Kidney Injury Test System","k":"2","r":"862.1220","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods."},{"c":"PIH","n":"Urethral Insert With Pump For Bladder Drainage","k":"2","r":"876.5140","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device is intended to empty urine from the bladder under patient control."},{"c":"PII","n":"Candida Species Nucleic Acid Detection System","k":"2","r":"866.3960","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification."},{"c":"PIJ","n":"Collagen Surgical Mesh Containing Drugs","k":"2","r":"878.3300","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Reinforcement of soft tissue where weakness exists."},{"c":"PIK","n":"Metabolic Neuromodulation System","k":"N","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The device treats type 2 diabetes through hepatic nerve denervation. The metabolic neuromodulation system consists of a monopolar single electrode ablation catheter and radio frequency generator and is intended to ablate the sympathetic nerves surrounding the common hepatic artery."},{"c":"PIL","n":"Test For Periprosthetic Joint Infection","k":"N","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"A qualitative in vitro diagnostic device intended as an adjunct for the detection of periprosthetic joint infection (PJI) in synovial fluid of patients experiencing pain and/or inflammation in a replacement joint."},{"c":"PIM","n":"Neuromodulator For Obesity","k":"3","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Weight reduction by peripheral neuromodulation."},{"c":"PIN","n":"Kidney Perfusion Kit","k":"2","r":"876.5880","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"PIO","n":"Enteral Specific Transition Connectors","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":3,"d":"Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors."},{"c":"PIP","n":"Prophy Powder, Airbrush Accessory","k":"2","r":"872.6080","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity."},{"c":"PIQ","n":"Reagents For Detection Of Norovirus Nucleic Acid","k":"2","r":"866.3990","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Qualitative in vitro diagnostic test for the rapid detection and differentiation of norovirus genogroup I and genogroup II from specimens e.g., stool collected from individuals with symptoms of acute gastroenteritis."},{"c":"PIR","n":"Mercy Tape 2d And 3d Models","k":"1","r":"878.4800","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC)."},{"c":"PIT","n":"Leishmania Spp. Antigen Detection Assay","k":"1","r":"866.3870","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection."},{"c":"PIV","n":"Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use","k":"2","r":"866.4750","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results."},{"c":"PIW","n":"Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid","k":"2","r":"882.1450","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."},{"c":"PIX","n":"Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":1,"d":"An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint."},{"c":"PIY","n":"Stainless Steel Instrument, Shunt System Implantation","k":"1","r":"882.4545","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A stainless steel shunt system implantation instrument is an instrument made entirely of stainless steel used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin."},{"c":"PIZ","n":"Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest."},{"c":"PJA","n":"Coronary Vascular Physiologic Simulation Software","k":"2","r":"870.1415","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease."},{"c":"PJB","n":"Catheter Remote Control System","k":"2","r":"870.5700","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"A steerable cardiac ablation catheter remote control system is a device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure."},{"c":"PJC","n":"Newborn Screening Specimen Collection Paper","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":3,"d":"Newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis."},{"c":"PJD","n":"Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing."},{"c":"PJE","n":"Blood/Plasma Collection Device For Dna Testing","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing."},{"c":"PJF","n":"Illuminator System For Blood Products","k":"3","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Preparation and storage of pathogen-reduced, blood components."},{"c":"PJG","n":"Cancer-Related Germline Gene Mutation Detection System","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens."},{"c":"PJH","n":"Dynamic Rectal Control System","k":"2","r":"876.5930","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended to treat fecal incontinence by controlling the size of the rectal lumen."},{"c":"PJI","n":"Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System","k":"2","r":"866.5930","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID)."},{"c":"PJJ","n":"Two Or More Sterilant Sterilizer","k":"2","r":"880.6860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities."},{"c":"PJK","n":"Tissue Adhesive For Internal Use","k":"3","r":"878.4010","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty."},{"c":"PJM","n":"Filler, Bone Void, Alterable Compound For Cranioplasty","k":"2","r":"882.5320","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material."},{"c":"PJN","n":"Filler, Bone Void, Non-Alterable Compound For Cranioplasty","k":"2","r":"882.5330","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material."},{"c":"PJO","n":"Fall Prevention Alarm/Sensor Combination Attached Or Unattached","k":"1","r":"880.2400","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it."},{"c":"PJP","n":"Fall Prevention Alarm/Sensor Attached Only","k":"1","r":"880.2400","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt ."},{"c":"PJQ","n":"Agent, Occluding, Vascular, Permanent","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":2,"d":"The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels."},{"c":"PJS","n":"Stimulator, Electrical, Implanted, For Essential Tremor","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Deep Brain Stimulation for the treatment of essential tremor"},{"c":"PJT","n":"Continuous Glucose Monitor Secondary Display","k":"2","r":"862.1350","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring"},{"c":"PJY","n":"Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb."},{"c":"PJZ","n":"Camera, Ophthalmic, General-Use","k":"2","r":"886.1120","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments."},{"c":"PKA","n":"External Upper Esophageal Sphincter (Ues) Compression Device","k":"2","r":"874.5900","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter."},{"c":"PKB","n":"Autosomal Recessive Carrier Screening Gene Mutation Detection System","k":"2","r":"866.5940","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing."},{"c":"PKC","n":"Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained","k":"2","r":"888.3660","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":20,"b":0,"e":3,"d":"Replacement of the humeral head for total anatomic shoulder arthroplasty"},{"c":"PKD","n":"Laceration Tray","k":"1","r":"878.4014","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":11,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PKE","n":"Laparoscopic Cholecystectomy Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PKF","n":"D And C Tray","k":"N","r":"","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"PKG","n":"Bone Marrow Processing Device To Support Hematopoietic Reconstitution","k":"2","r":"864.9245","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Processing of bone marrow harvested from human donors to support hematopoietic reconstitution in a recipient."},{"c":"PKI","n":"Fully Subcutaneous Implanted Hemodialysis Catheter","k":"2","r":"876.5540","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Provides access to the blood for hemodialysis or other chronic uses."},{"c":"PKJ","n":"Crown And Bridge Material, Resin Based","k":"N","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications."},{"c":"PKK","n":"Stent Delivery System","k":"N","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"For coarctation of the aorta"},{"c":"PKL","n":"Hemostatic Metal Clip For The Gi Tract","k":"2","r":"876.4400","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":67,"b":0,"e":6,"d":"Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations."},{"c":"PKM","n":"Chemiluminescent Immunoassay System","k":"N","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum."},{"c":"PKN","n":"Dilator, Cervical, Synthetic, Osmotic","k":"2","r":"884.4260","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Cervical softening and dilation"},{"c":"PKO","n":"Transparent Patch For Use In Treatment Of Tattoos","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To reduce formation of bubbles during laser treatment of tattoos."},{"c":"PKP","n":"Immunoglobulin G (Igg) Infusion System","k":"2","r":"880.5725","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling."},{"c":"PKQ","n":"Computerized Cognitive Assessment Aid","k":"2","r":"882.1470","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time"},{"c":"PKR","n":"Non-Invasive Vagus Nerve Stimulator - Headache","k":"2","r":"882.5892","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks."},{"c":"PKS","n":"Exerciser, Non-Measuring For Stroke Rehabilitation","k":"1","r":"890.5370","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion."},{"c":"PKT","n":"Laser For Disruption Of Adipocyte Cells For Aesthetic Use","k":"2","r":"878.5400","p":"SU","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":19,"b":0,"e":0,"d":"Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.","x":-1},{"c":"PKU","n":"Insulin Pump Secondary Display","k":"2","r":"862.1350","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring."},{"c":"PKW","n":"Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The anaplastic lymphoma kinase (ALK) antibody is a qualitative immunohistochemical antibody intended to identify ALK protein expression in human clinical tissue specimens. The ALK antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"PKY","n":"Implant, Dermal, For Aesthetic Use In The Hands","k":"3","r":"","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"For hand augmentation to correct volume loss in the dorsum of the hands."},{"c":"PLA","n":"Esophageal Thermal Regulation And Gastric Suctioning Device","k":"2","r":"870.5910","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage."},{"c":"PLB","n":"Multivariate Vital Signs Index","k":"2","r":"870.2300","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs."},{"c":"PLC","n":"Sleep Appliances With Patient Monitoring","k":"2","r":"872.5570","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy."},{"c":"PLF","n":"Bone Wedge","k":"2","r":"888.3030","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":18,"b":0,"e":9,"d":"Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia."},{"c":"PLH","n":"Orthodontic Led Accessory","k":"2","r":"872.5470","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement."},{"c":"PLI","n":"Gastrointestional Tube Holder","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to support, secure, and hold gastrointestinal tubes"},{"c":"PLJ","n":"Tissue Adhesive Internal Use","k":"3","r":"878.4010","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended for the fixation of surgical meshes."},{"c":"PLK","n":"Tympanic Membrane Direct Contact Hearing Aid","k":"2","r":"874.3315","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane."},{"c":"PLL","n":"Submucosal Injection Agent","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":1,"d":"Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device."},{"c":"PLO","n":"Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System","k":"2","r":"866.3970","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":2,"d":"A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings."},{"c":"PLP","n":"High Intensity Ultrasound System For Prostate Tissue Ablation","k":"2","r":"876.4340","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":1,"d":"Prostate tissue ablation"},{"c":"PLQ","n":"Enzyme Packed Cartridge","k":"2","r":"876.5985","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"Hydrolyze fats in enteral formula."},{"c":"PLR","n":"Spinal Vertebral Body Replacement Device - Cervical","k":"2","r":"888.3060","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":19,"b":0,"e":0,"d":"Vertebral body replacement in the cervical spine."},{"c":"PLS","n":"Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":6,"e":2,"d":"The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs."},{"c":"PLU","n":"Thermal System For Insomnia","k":"2","r":"882.5700","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface."},{"c":"PLV","n":"Dental Stereotaxic Instrument","k":"2","r":"872.4120","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":23,"b":0,"e":6,"d":"To facilitate dental implant placement in patients that are partially endentulous or edentulous."},{"c":"PLW","n":"Acetabular Cup Orientation System","k":"2","r":"888.3350","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans."},{"c":"PLX","n":"Tear Duct Occluder","k":"1","r":"886.5838","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the duct."},{"c":"PLY","n":"Antimicrobial Drapes","k":"2","r":"878.4370","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Used to reduce the risk of skin flora contamination of the surgical wound during a surgical procedure."},{"c":"PLZ","n":"Ocular Pattern Recorder","k":"2","r":"886.1925","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation."},{"c":"PMB","n":"External Airway","k":"2","r":"868.5105","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is intended to maintain airway patency using negative pressure during mild to moderate sedation."},{"c":"PMC","n":"Scalp Cooling System","k":"2","r":"878.4360","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used."},{"c":"PME","n":"External Cleaning Solution","k":"2","r":"872.3260","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":3,"b":0,"e":0,"d":"For use on dental restorations, external to the mouth, prior to insertion into the mouth."},{"c":"PMG","n":"Automated Multicolor Fluorescent Imaging Cytometric Analysis System","k":"2","r":"864.5220","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements."},{"c":"PMH","n":"Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)","k":"F","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For treatment of fecal incontinence in patients who have failed conservative therapies"},{"c":"PMI","n":"Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement","k":"3","r":"","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"A fluorescence in situ hybridization (FISH) assay for PDGFRB rearrangement is a qualitative in vitro diagnostic assay to detect large rearrangements or translocations within the PDGFRB gene locus. It is indicated as an aid in the assessment of patients for whom treatment with tyrosine kinase inhibitors might be appropriate."},{"c":"PMJ","n":"Cpr Aid Feedback Device (No Software)","k":"2","r":"870.5210","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines"},{"c":"PMK","n":"Cpr Aid Device Without Feedback","k":"1","r":"870.5210","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim."},{"c":"PML","n":"Bone Cement, Posterior Screw Augmentation","k":"2","r":"888.3027","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":19,"b":0,"e":2,"d":"The device is intended to augment the fixation of screws in a posterior spinal system construct."},{"c":"PMN","n":"Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays","k":"2","r":"866.3920","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":33,"b":0,"e":4,"d":"Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use."},{"c":"PMP","n":"Dorsal Root Ganglion Stimulator For Pain Relief","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":2,"d":"Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs."},{"c":"PMQ","n":"Peripheral Blood Processing Device For Wound Management","k":"2","r":"864.9245","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management."},{"c":"PMS","n":"Peripheral Intravenous (Piv) Infiltration Monitor","k":"2","r":"880.5725","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations."},{"c":"PMT","n":"Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock."},{"c":"PMU","n":"Containment System, Laparoscopic Power Morcellation, With Instrument Port","k":"2","r":"884.4050","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation."},{"c":"PMV","n":"Orthosis, Limb, For Back Pain","k":"1","r":"890.3475","p":"PM","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.","x":36},{"c":"PMW","n":"Strabismus Detection Device","k":"2","r":"886.1342","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"For the automated detection of misalignment of the visual axes for prescription use only."},{"c":"PMX","n":"Absorbable Collagen Hemostatic Agent With Thrombin","k":"3","r":"878.4490","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":4,"e":2,"d":"Intended for use as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical."},{"c":"PMY","n":"System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony","k":"2","r":"866.1640","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology."},{"c":"PNA","n":"Evoked Photon Image Capture Device","k":"1","r":"882.1561","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin."},{"c":"PNB","n":"Biliary Stent System For Benign Strictures","k":"2","r":"876.5011","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts."},{"c":"PNC","n":"Catheter Introducer","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The catheter introducer is intended to provide a path for a catheter to be placed near nerves or into and around wound sites for the delivery local anesthesia."},{"c":"PND","n":"Midline Catheter","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":10,"d":"The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days."},{"c":"PNE","n":"Reprocessed Catheter Introducer","k":"2","r":"870.1340","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"Introduce various cardiovascular catheters into the heart and cardiovascular system"},{"c":"PNF","n":"Aortic Stent","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"Coarctation of the Aorta"},{"c":"PNG","n":"Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling","k":"2","r":"876.5630","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":15,"b":0,"e":13,"d":"For drainage of refractory ascites with long-term occurrence from the peritoneal cavity."},{"c":"PNI","n":"Aquaporin-4 Autoantibody","k":"2","r":"866.5665","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings."},{"c":"PNJ","n":"Leadless Pacemaker","k":"3","r":"870.3610","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":6,"d":"To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary."},{"c":"PNK","n":"Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)","k":"2","r":"864.1890","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":1,"e":0,"d":"A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL)."},{"c":"PNL","n":"Magnetic Surgical System","k":"2","r":"878.4815","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only."},{"c":"PNN","n":"Orthodontic Software","k":"2","r":"872.5470","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":37,"b":0,"e":2,"d":"The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only."},{"c":"PNO","n":"Catheter, Percutaneous, Cutting/Scoring","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":47,"b":0,"e":3,"d":"To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material"},{"c":"PNP","n":"Dental Abutment Design Software For Dental Laboratory","k":"2","r":"872.3630","p":"DE","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment."},{"c":"PNQ","n":"Apical Closure Device","k":"2","r":"870.4510","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is intended for closure of cardiac apical tissue."},{"c":"PNR","n":"Enteral Syringes With Enteral Specific Connectors","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":34,"b":0,"e":4,"d":"Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors."},{"c":"PNS","n":"Short-Term Intravascular Filter Catheter","k":"2","r":"870.3375","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For short-term prevention of pulmonary embolism (PE)"},{"c":"PNU","n":"Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery","k":"2","r":"884.5210","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery"},{"c":"PNV","n":"Impedance Measuring Device Utilizing Oscillation Techniques","k":"2","r":"868.1840","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"This device measures respiratory impedance."},{"c":"PNW","n":"Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"The device is a metatarsophalangeal joint cartilage replacement device that is implanted in the metatarsal head of the first metatarsophalangeal joint."},{"c":"PNY","n":"Absorbable Coronary Drug-Eluting Stent","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis."},{"c":"PNZ","n":"Eustachian Tube Balloon Dilation Device","k":"2","r":"874.4180","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction."},{"c":"POA","n":"Reagents, Zika Virus Nucleic Acid","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":1,"d":"Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens."},{"c":"POC","n":"System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen","k":"2","r":"866.1640","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology."},{"c":"POD","n":"Temporary, Internal Use Hemostatic","k":"2","r":"878.4454","p":"SU","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":1,"d":"Intended to control severely bleeding wounds"},{"c":"POE","n":"Extended Depth Of Focus Intraocular Lens","k":"3","r":"886.3600","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":4,"e":1,"d":"Intended to be implanted to replace the natural lens of an eye."},{"c":"POG","n":"Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens"},{"c":"POH","n":"Mr-Guided Focused Ultrasound System","k":"3","r":"","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device during the procedure."},{"c":"POI","n":"Lung Tissue Sealant For Lung Volume Reduction","k":"N","r":"","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both small airways and collateral air channels through sealing lung tissue, causing the treated area to collapse via absorption atelectasis. It is a single use device intended to be used by pulmonologists and thoracic surgeons in a bronchoscopy suite or operating room."},{"c":"POK","n":"Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer","k":"2","r":"892.2060","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":24,"b":0,"e":0,"d":"Assist users in characterizing lesions identified on acquired medical images"},{"c":"POL","n":"Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment","k":"2","r":"882.5600","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":18,"b":0,"e":3,"d":"A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature."},{"c":"POM","n":"Computerized Cognitive Assessment Aid For Concussion","k":"2","r":"882.1471","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"For use as an assessment aid in the management of concussion."},{"c":"PON","n":"Catheter, Balloon, Dilation Of Cervical Canal","k":"2","r":"884.4260","p":"OB","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Mechanical dilation and softening of the cervix."},{"c":"POP","n":"Cranial Motion Measurement Device","k":"2","r":"882.1630","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes."},{"c":"POQ","n":"Blood Transfusion Kit","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":5,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"POR","n":"Parenteral Administration Kit","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market."},{"c":"POS","n":"Physiological Signal Based Seizure Monitoring System","k":"2","r":"882.1580","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":1,"d":"The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device."},{"c":"POT","n":"Lockbox (Export Only)","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"The lockbox is intended to hold an infusion pump and keep the medication syringe contained within the pump relatively secure."},{"c":"POV","n":"Semen Analysis Device","k":"2","r":"864.5220","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":28,"b":0,"e":2,"d":"Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH."},{"c":"POW","n":"Crown And Bridge, Long-Term Temporary, Resin","k":"2","r":"872.3770","p":"DE","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For the fabrication of long-term temporary crowns and bridges"},{"c":"POX","n":"Enzyme Immunoassay, Oxcarbazepine Metabolite","k":"2","r":"862.3645","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An Oxcarbazepine Metabolite Assay is an enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy."},{"c":"POY","n":"Post Breast Biopsy Hemostatic Breast Compression Device","k":"2","r":"892.1710","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To achieve and maintain hemostasis of a breast biopsy wound site."},{"c":"POZ","n":"Biopsy Needle Kit","k":"2","r":"876.1075","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPA","n":"Bladder Irrigation Kit","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPB","n":"Foley Catheter Kit (Excludes Hiv Testing)","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":14,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPC","n":"Male External Catheterization Kit (Excludes Hiv Testing)","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPD","n":"Universal Drainage Tray","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":4,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPE","n":"Nephroscope Set","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPF","n":"Urinary Irrigation Kit","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPG","n":"Urinary Drainage Collection Kit","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPH","n":"Single Needle With Uni-Directional Pump Kit","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPI","n":"Hemodialysis Tray (Not A Start/Stop Kit)","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPJ","n":"Peritoneal Dialysis Administration Kit","k":"2","r":"876.5630","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPK","n":"Peritoneal Dialysis Tubing Kit","k":"2","r":"876.5630","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPL","n":"Single Needle (Co-Axial Flow) Dialysis Kit","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPM","n":"General Purpose Reagent","k":"1","r":"864.4010","p":"PA","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":16,"b":0,"e":30,"d":"A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.","x":9},{"c":"PPN","n":"Percutaneous Catheter, Ultrasound","k":"2","r":"870.1250","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":14,"b":0,"e":1,"d":"Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature."},{"c":"PPO","n":"Multi-Lumen Hemodialysis Catheterization Kit","k":"2","r":"876.5540","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":2,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPP","n":"Disposable Joint Aspiration/Injection Kit","k":"1","r":"878.4800","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.Fda.Gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.Pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPQ","n":"Transtibial Anterior Cruciate Ligament Kit","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPR","n":"Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures","k":"2","r":"888.1100","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PPS","n":"Sleeve, Head And Neck, Compressible","k":"2","r":"870.5800","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended to move excess fluid from the target area to another area of the body."},{"c":"PPT","n":"Cranial Surgical Planning And Instrument Guides","k":"2","r":"882.4310","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures."},{"c":"PPU","n":"Microbial Colony Image Assessment System","k":"2","r":"866.2190","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist."},{"c":"PPW","n":"Adjunctive Cardiovascular Status Indicator","k":"2","r":"870.2200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."},{"c":"PQA","n":"Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System","k":"2","r":"866.3975","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":13,"b":0,"e":3,"d":"A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections."},{"c":"PQC","n":"Pedicle Screw Placement Guide","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans."},{"c":"PQD","n":"Blood Specimen Collection Convenience Kit (Excludes Hiv)","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PQE","n":"Ostomy Care Kit","k":"1","r":"876.5900","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PQF","n":"Sensor, Glucose, Invasive, Non-Adjunctive","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":2,"e":4,"d":"A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments."},{"c":"PQH","n":"Iodinated Contrast Media Transfer Tubing Set","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple sterile single use syringes from an imaging bulk package contrast media bulk package under controlled ambient filling conditions such as a CT suite."},{"c":"PQI","n":"Wound Retraction And Protection System","k":"2","r":"878.4371","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound."},{"c":"PQJ","n":"Intranasal Electrostimulation Device","k":"2","r":"886.5300","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device type is intended to temporarily increase tear production using neurostimulation in adult patients."},{"c":"PQK","n":"Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access","k":"2","r":"870.1252","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis."},{"c":"PQM","n":"Surgical Smoke Precipitator","k":"2","r":"878.5050","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools."},{"c":"PQN","n":"Carbon Dioxide Gas Controlled Tissue Expander","k":"2","r":"878.3510","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A carbon dioxide gas controlled tissue expander is intended for tissue expansion."},{"c":"PQO","n":"Anti-Müllerian Hormone Test System","k":"2","r":"862.1092","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"An Anti-Müllerian hormone test system is an in vitro diagnostic device intended to measure anti-Müllerian hormone in human serum and plasma. The test is intended to be used as an aid for assessing ovarian reserve in women."},{"c":"PQP","n":"Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":18,"e":18,"d":"A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens."},{"c":"PQQ","n":"Data Acquisition Software","k":"2","r":"862.2570","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments."},{"c":"PQT","n":"Alpha-L-Iduronidase (Idua) Newborn Screening Test System","k":"2","r":"862.1488","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for quantitative measurement of the activity of alpha-L-iduronidase (IDUA) from newborn dried blood spot specimens."},{"c":"PQU","n":"Alpha-D-Glucosidase (Gaa) Newborn Screening Test System","k":"2","r":"862.1488","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For quantitative measurement of the activity of alpha-D-glucosidase (GAA) from newborn dried blood spot specimens."},{"c":"PQV","n":"ß-Glucocerebrosidase (Gba) Newborn Screening Test System","k":"2","r":"862.1488","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For quantitative measurement of the activity of ß-glucocerebrosidase (GBA) from newborn dried blood spot specimens."},{"c":"PQW","n":"Alpha-D-Galactosidase A (Gla) Newborn Screening Test System","k":"2","r":"862.1488","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens."},{"c":"PQX","n":"Epinephrine Syringe","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended for intramuscular or subcutaneous injection of epinephrine."},{"c":"PQY","n":"Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain","k":"2","r":"890.5290","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain."},{"c":"PQZ","n":"Gbs Culture Media, Selective And Differential","k":"1","r":"866.2360","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":3,"d":"Culture Medium for GBS Detection"},{"c":"PRA","n":"Variola Virus Nucleic Acid-Based Detection Assay","k":"2","r":"866.3316","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government."},{"c":"PRB","n":"Cervical Intraepithelial Neoplasia (Cin) Test System","k":"2","r":"864.1865","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":3,"d":"The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information."},{"c":"PRC","n":"Drug-Coated Peripheral Transluminal Angioplasty Catheter","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency"},{"c":"PRE","n":"Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood."},{"c":"PRF","n":"Docetaxel / Paclitaxel Assay","k":"N","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Measures levels of Docetaxel or Paclitaxel in the blood"},{"c":"PRH","n":"Positive Blood Culture Identification And Ast Kit","k":"2","r":"866.1650","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":4,"d":"Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets."},{"c":"PRI","n":"Procalcitonin Assay","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":8,"b":0,"e":1,"d":"To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)."},{"c":"PRJ","n":"Capillary Blood Collection Device For Alternative Site Collection","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes."},{"c":"PRK","n":"Device Indicating An Exhalation Event","k":"2","r":"868.2375","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To provide visual indication of each exhalation event"},{"c":"PRL","n":"Iliac Covered Stent, Arterial","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":6,"d":"For the treatment of de novo or restenotic lesions found in iliac arteries"},{"c":"PRM","n":"Enteral Administration Kit (Adult & Pediatric)","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRN","n":"Pediatric Position Holder","k":"1","r":"880.5680","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Device used to physically restrain a pediatric patient for a short surgical or clinical procedure such as circumcision. Not intended for prolonged positioning."},{"c":"PRO","n":"Anti-Regurgitation Blood Tubing Kit","k":"2","r":"876.5820","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRP","n":"Balloon Gastrostomy Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRQ","n":"Esophageal Dilator Kit","k":"2","r":"876.5365","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRR","n":"Feeding Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRS","n":"Gastric Colonic Catheter Irrigation Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRT","n":"Gastric Irrigation And Aspiration Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRU","n":"Gastric Lavage Kit (Adult Or Pediatric Use)","k":"2","r":"876.4370","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRV","n":"Gastro-Urology Biopsy Kit","k":"2","r":"876.1075","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRW","n":"Gastrointestinal Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRX","n":"Gastrostomy Guide Wire Placement Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRY","n":"Gastrostomy Jejunostomy Feeding Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PRZ","n":"Gastrostomy Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSA","n":"Laparoscopic Jejunostomy Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSB","n":"Nasogastric Feed Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSC","n":"Nasogastric-Gastrojejunal Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSD","n":"Laparoscopic Gastrostomy Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSE","n":"Needle Catheter Jejunostomy Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSF","n":"Non-Balloon Replacement Gastrostomy System","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSG","n":"Percutaneous Endoscopic Gastrostomy Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSH","n":"Percutaneous Replacement Gastrostomy Tube Kit","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSI","n":"Perineal Irrigation Kit","k":"2","r":"876.5980","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSJ","n":"Rectal Dilator Kit","k":"1","r":"876.5450","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSK","n":"Replacement Gastrostomy Feeding Catheter Tray","k":"2","r":"876.5980","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSL","n":"25-Oh-Vitamin D Mass Spectrometry Test System","k":"2","r":"862.1840","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry."},{"c":"PSM","n":"Refractometer For Donor Testing","k":"1","r":"862.2800","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"For total protein testing of plasma donors to determine eligibility."},{"c":"PSN","n":"Light Based Imaging","k":"2","r":"878.4580","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Eligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"Emission and collection of light to create an image for medical purposes"},{"c":"PSP","n":"Intracranial Pressure & Temperature Monitoring Kit","k":"2","r":"882.1620","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PSQ","n":"Intracardiac Patch Or Pledget, Biologically Derived","k":"2","r":"870.3470","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":11,"b":0,"e":2,"d":"To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature."},{"c":"PSR","n":"Implanted Phrenic Nerve Stimulator For Central Sleep Apnea","k":"3","r":"","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep."},{"c":"PSS","n":"Minoxidil Sulfotransferase Or Isoenzymes Test System","k":"N","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"For measurement of Minoxidil sulfotransferase as an aid in assessing the likelihood that a patient will respond to minoxidil."},{"c":"PST","n":"Aortic Annuloplasty Ring","k":"2","r":"870.3800","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To correct annular dilatation and/or maintain annular geometry of the aortic valve."},{"c":"PSU","n":"Jak2 Gene Mutation Detection Test","k":"2","r":"866.6070","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors."},{"c":"PSV","n":"Ultrasound Bronchoscope","k":"2","r":"892.1550","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":2,"d":"An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"PSW","n":"High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid","k":"2","r":"892.1570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)."},{"c":"PSX","n":"Chlorine Meter","k":"2","r":"876.5665","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"These devices are intended to measure chlorine levels in water."},{"c":"PSY","n":"Whole Slide Imaging System","k":"2","r":"864.3700","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":23,"b":0,"e":2,"d":"The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear)."},{"c":"PSZ","n":"Devices Detecting Influenza A, B, And C Virus Antigens","k":"2","r":"866.3328","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":73,"b":0,"e":5,"d":"An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection."},{"c":"PTA","n":"Genetic Variant Detection And Health Risk Assessment System","k":"2","r":"866.5950","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":5,"b":0,"e":0,"d":"A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease."},{"c":"PTB","n":"Ataxiagraph With Interpretive Software","k":"1","r":"882.1030","p":"NE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement."},{"c":"PTC","n":"Uric Acid Test System For At Home Prescription Use","k":"1","r":"862.1775","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only."},{"c":"PTD","n":"Subcutaneous Implanted Apheresis Port","k":"2","r":"880.5965","p":"HO","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis"},{"c":"PTE","n":"Endoscopic Morcellator Gastroenterology","k":"2","r":"884.1690","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)"},{"c":"PTF","n":"Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock"},{"c":"PTG","n":"Test, Methadone, Over The Counter","k":"2","r":"862.3620","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine."},{"c":"PTH","n":"Test, Barbiturate, Over The Counter","k":"2","r":"862.3150","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine."},{"c":"PTI","n":"Non-Coring (Huber) Needle","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":14,"b":0,"e":12,"d":"The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums."},{"c":"PTJ","n":"Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates","k":"2","r":"866.1640","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem"},{"c":"PTK","n":"Pediatric Esophageal Atresia Anastomosis Device","k":"3","r":"876.5980","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter."},{"c":"PTL","n":"Wire, Guide, Catheter, Exempt","k":"2","r":"870.1330","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTM","n":"Syringe, Balloon Inflation, Exempt","k":"2","r":"870.1650","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":7,"d":"This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTN","n":"Reservoir, Blood, Cardiopulmonary Bypass, Exempt","k":"2","r":"870.4400","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTO","n":"Tester, Auditory Impedance, Exempt","k":"2","r":"874.1090","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of ETY, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 874.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTP","n":"Tympanometer, Exempt","k":"2","r":"874.1090","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of NAS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 874.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTQ","n":"Endoscopic Magnetic Retriever, Exempt","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of FCC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTR","n":"Scissors For Cytoscope, Exempt","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of KGD, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTS","n":"Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTT","n":"Biliary Catheter For Irrigation And Contrast Injection, Exempt","k":"2","r":"876.5010","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTU","n":"Catheter, Peritoneal, Long-Term Indwelling, Exempt","k":"2","r":"876.5630","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTV","n":"Catheter, Peritoneal Dialysis, Single Use, Exempt","k":"2","r":"876.5630","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of FKO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTW","n":"System, Peritoneal, Automatic Delivery, Exempt","k":"2","r":"876.5630","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of FKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTX","n":"Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt","k":"2","r":"878.4495","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of GAQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTY","n":"Computerized Cognitive Assessment Aid, Exempt","k":"2","r":"882.1470","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of PKQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 882.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PTZ","n":"Colposcope (And Colpomicroscope), Exempt","k":"2","r":"884.1630","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUA","n":"Tenaculum, Uterine, Exempt","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of HDC, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUB","n":"Accessory, Assisted Reproduction, Exempt","k":"2","r":"884.6120","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":6,"d":"This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUC","n":"Microtools, Assisted Reproduction (Pipettes), Exempt","k":"2","r":"884.6130","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of MQH, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUD","n":"Labware, Assisted Reproduction, Exempt","k":"2","r":"884.6160","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of MQK, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUE","n":"Biomicroscope, Slit-Lamp, Ac-Powered, Exempt","k":"2","r":"886.1850","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUF","n":"Ocular Peg, Exempt","k":"2","r":"886.3320","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of MQU, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUG","n":"Analyzer, Nitrogen Dioxide, Exempt","k":"2","r":"868.2385","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of MRQ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 868.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUH","n":"Analyzer, Body Composition, Exempt","k":"2","r":"870.2770","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of MNW, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUI","n":"Drape, Surgical, Exempt","k":"2","r":"878.4370","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":54,"d":"This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"PUJ","n":"Voriconazole Test System","k":"2","r":"862.3970","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy."},{"c":"PUK","n":"Administration Set Securement Device","k":"1","r":"880.5210","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Accessory device that secures intravenous administration sets (IV lines/tubing) to mobile transport devices."},{"c":"PUL","n":"Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered","k":"2","r":"886.4100","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Used to perform anterior capsulotomy during cataract surgery"},{"c":"PUM","n":"Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures","k":"2","r":"870.1251","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Embolic protection for transcatheter intracardiac procedures"},{"c":"PUN","n":"Lice Removal Kit Containing A Solution","k":"1","r":"880.5960","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To remove lice eggs from hair"},{"c":"PUP","n":"Endoscope Maintenance System","k":"2","r":"876.1500","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments."},{"c":"PUQ","n":"Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm","k":"2","r":"866.3510","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma."},{"c":"PUR","n":"Vacuum Syringe","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid."},{"c":"PUU","n":"Temporary Coil Embolization Assist Device","k":"2","r":"882.5955","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed."},{"c":"PUV","n":"Lymph Node Location System During Sentinel Biopsy Procedure","k":"3","r":"","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Locating lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure"},{"c":"PUW","n":"System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens","k":"2","r":"866.5750","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PUX","n":"Test, Amphetamine, Employment And Insurance Testing, Exempt","k":"2","r":"862.3100","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The amphetamine test is an in vitro diagnostic test for the qualitative analysis of amphetamine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PUY","n":"Test, Barbiturate, Employment And Insurance Testing, Exempt","k":"2","r":"862.3150","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PUZ","n":"Test, Benzodiazepine, Employment And Insurance Testing, Exempt","k":"2","r":"862.3170","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The benzodiazepine test is an in vitro diagnostic test for the qualitative analysis of benzodiazepines for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVA","n":"Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt","k":"2","r":"862.3250","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The cocaine and cocaine metabolite test is an in vitro diagnostic test for the qualitative analysis of cocaine and cocaine metabolites for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVB","n":"Test, Codeine, Employment And Insurance Testing, Exempt","k":"2","r":"862.3270","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The codeine test is an in vitro diagnostic test for the qualitative analysis of codeine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVC","n":"Test, Lsd, Employment And Insurance Testing, Exempt","k":"2","r":"862.3580","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The LSD test is an in vitro diagnostic test for the qualitative analysis of LSD for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVD","n":"Test, Methamphetamine, Employment And Insurance Testing, Exempt","k":"2","r":"862.3610","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The methamphetamine test is an in vitro diagnostic test for the qualitative analysis of methamphetamines for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVE","n":"Test, Methadone, Employment And Insurance Testing, Exempt","k":"2","r":"862.3620","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Test, methadone, employment and insurance testing, exempt FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVF","n":"Test, Methaqualone, Employment And Insurance Testing, Exempt","k":"2","r":"862.3630","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The methaqualone test is an in vitro diagnostic test for the qualitative analysis of methaqualone for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVG","n":"Test, Morphine, Employment And Insurance Testing, Exempt","k":"2","r":"862.3640","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The morphine test is an in vitro diagnostic test for the qualitative analysis of morphine for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVH","n":"Test, Opiates, Employment And Insurance Testing, Exempt","k":"2","r":"862.3650","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVI","n":"Test, Propoxyphene, Employment And Insurance Testing, Exempt","k":"2","r":"862.3700","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The propoxyphene test is an in vitro diagnostic test for the qualitative analysis of propoxyphene for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVJ","n":"Test, Cannabinoid, Employment And Insurance Testing, Exempt","k":"2","r":"862.3870","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVK","n":"Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt","k":"2","r":"862.3910","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The tricyclic antidepressant drugs test is an in vitro diagnostic test for the qualitative analysis of tricyclic antidepressant drugs for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing."},{"c":"PVL","n":"Endoscopic Shunt Placement Kit","k":"2","r":"882.5550","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVM","n":"Endoscopic Ventricular Catheter Placement Kit","k":"2","r":"882.4100","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVO","n":"Lumbar Drainage Catheter Kit","k":"2","r":"882.5550","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVP","n":"Neurological Test Kit","k":"1","r":"882.1750","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVQ","n":"Rickettsia Spp. Nucleic Acid Based Detection Assay","k":"2","r":"866.3316","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government."},{"c":"PVR","n":"D&C Tray","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVS","n":"Fetal Blood Sampling Kit (Excludes Hiv Testing)","k":"2","r":"884.1560","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVT","n":"Maternity Kit","k":"1","r":"884.5435","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVU","n":"Obstetrical Anesthesia Kit","k":"2","r":"884.5100","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVV","n":"Paracervical Anesthesia Kit","k":"2","r":"884.5100","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVW","n":"Pudendal Anesthesia Kit","k":"2","r":"884.5100","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVX","n":"Vaginal Examination Tray","k":"2","r":"884.4530","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVY","n":"Vasovasostomy Set","k":"1","r":"876.4730","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PVZ","n":"Non-Stainless Steel Needle","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"A hypodermic needle is intended to inject medication and aspirate fluid, below the surface of the skin. Designed to be used with ultrasound for better visualization of needle during use."},{"c":"PWA","n":"Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure","k":"1","r":"884.5150","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Designed to be used in conjunction with powered or non-powered breast pumps to apply positive pressure to the breast to aid in milk expression from the breasts of a nursing woman."},{"c":"PWB","n":"Fetal Head Elevator","k":"2","r":"884.4350","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery."},{"c":"PWC","n":"General Wellness Product","k":"N","r":"","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":3,"d":"General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf"},{"c":"PWD","n":"Flow Cytometric Test System For Hematopoietic Neoplasms","k":"2","r":"864.7010","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN)"},{"c":"PWE","n":"Computerized Behavioral Therapy Device For Substance Use Disorders","k":"2","r":"882.5801","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":2,"d":"The device is intended to provide cognitive behavioral therapy to treat substance use disorder."},{"c":"PWG","n":"Spinal Fixation System","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Stabilization of the posterior thoracic and lumbar spine"},{"c":"PWH","n":"Administrations Sets With Neuraxial Connectors","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections."},{"c":"PWI","n":"Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse","k":"2","r":"884.4910","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":13,"d":"Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair"},{"c":"PWJ","n":"Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence","k":"2","r":"884.4910","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence"},{"c":"PWK","n":"Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse","k":"2","r":"884.4910","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair"},{"c":"PWL","n":"Oral Surgery Tray","k":"1","r":"872.4565","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":15,"d":"This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWM","n":"Admission Kit (Patient Utensil)","k":"1","r":"880.6730","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWN","n":"Baby Care Kit","k":"2","r":"880.5700","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWO","n":"Blood Administration Kit","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWP","n":"Blood Borne Pathogen Response Kit","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWQ","n":"Buret Administration Intravenous Kit","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWR","n":"Catheter Repair Kit","k":"2","r":"880.5970","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWS","n":"Chemotherapy Administration Kit","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWT","n":"Chemotherapy Spill Clean-Up Kit","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWU","n":"Clean-Up Kit","k":"1","r":"880.6890","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWV","n":"Delivery Room Apparel Kit","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWW","n":"Fever Monitoring Kit","k":"2","r":"880.2910","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWX","n":"Insect Sting Emergency Kit","k":"1","r":"880.5740","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWY","n":"Lumbar Puncture Tray (Adult & Pediatric)","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":21,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PWZ","n":"Mid-Stream Collection Kit","k":"1","r":"880.6730","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXA","n":"Oral Administration Set","k":"1","r":"880.6430","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXB","n":"Percutaneous Introducer Kit","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXC","n":"Personal Protection Kit","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXD","n":"Prep Kit","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXE","n":"Pressure Monitoring (Air/Gas) Kit","k":"1","r":"868.2610","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXF","n":"Sitz Bath Kit","k":"1","r":"880.6730","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXG","n":"Spill Kit","k":"1","r":"880.6890","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXH","n":"Thermometer Kit","k":"2","r":"880.2910","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXI","n":"Thoracentesis Tray","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":19,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXJ","n":"Umbilical Catheter Insertion Tray","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXK","n":"Vascular Access Port Kit","k":"2","r":"880.5965","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXL","n":"Venipuncture Kit","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXM","n":"Vomitus Clean-Up Kit","k":"1","r":"880.6890","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXN","n":"Basic Set-Up Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXO","n":"Bone Marrow Biopsy Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":3,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXP","n":"Breast Biopsy / Localization Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":8,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXQ","n":"Burn Dressing Tray","k":"1","r":"878.4022","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXR","n":"Cement And Bone Removal Kit","k":"1","r":"878.4820","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXS","n":"Cholecystectomy Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXU","n":"Fluid Drainage Tray","k":"1","r":"878.4200","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXV","n":"General Purpose Instrument Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXW","n":"Herniorraphy Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXX","n":"Incision Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXY","n":"Irrigation Kit (Wounds)","k":"1","r":"878.4014","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PXZ","n":"Laparascopic Sphincterotomy Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYA","n":"Liver Biopsy Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYB","n":"Minor Surgical Procedures Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYC","n":"Paracentesis Tray","k":"1","r":"878.4200","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":6,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYD","n":"Pelviscopy Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYE","n":"Staple Removal Kit","k":"1","r":"878.4760","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":1,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYF","n":"Sterile Puncture Tray","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYG","n":"Suction Catheter Kit","k":"1","r":"878.4200","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYH","n":"Surgical Retractor Kit","k":"1","r":"878.4800","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYI","n":"Thoracic Catheter Insertion Tray","k":"1","r":"878.4200","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYJ","n":"Ulcer Wound Tray","k":"1","r":"878.4014","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYK","n":"Venous Ulcer Kit","k":"1","r":"878.4014","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYL","n":"Wound Drainage Kit","k":"1","r":"878.4014","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PYN","n":"Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.","k":"2","r":"866.3367","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection."},{"c":"PYO","n":"Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use","k":"1","r":"880.5240","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin"},{"c":"PYP","n":"Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test","k":"1","r":"862.1475","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions."},{"c":"PYQ","n":"Rfid Chip For Dental Appliance","k":"2","r":"880.6300","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The device is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures, and other removable oral appliances."},{"c":"PYR","n":"Neuraxial Administration Set - Intrathecal Delivery","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Neuraxial Administration Sets used to deliver fluids to the intrathecal space."},{"c":"PYS","n":"Zika Virus Serological Reagents (Emergency Use)","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings."},{"c":"PYT","n":"Device, Fertility Diagnostic, Contraceptive, Software Application","k":"2","r":"884.5370","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"Designed to monitor and provide fertility information to prevent pregnancy (contraception)."},{"c":"PYU","n":"Sponge, Eyelid Cleaning, Powered","k":"1","r":"878.4820","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional."},{"c":"PYV","n":"Hospital Continuous Glucose Monitoring System","k":"2","r":"862.1345","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting."},{"c":"PYX","n":"Temporary Non-Roller Type Right Heart Support Blood Pump","k":"3","r":"870.4360","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":7,"d":"Providing temporary partial or full right heart circulatory support."},{"c":"PZC","n":"Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue","k":"N","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"An Imaged-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue."},{"c":"PZE","n":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":3,"d":"A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments."},{"c":"PZF","n":"Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System","k":"2","r":"866.4001","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities."},{"c":"PZG","n":"Surgical Eye Tray","k":"1","r":"886.4350","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":6,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"PZH","n":"Serpina1 Variant Detection System","k":"2","r":"866.5130","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency."},{"c":"PZI","n":"Prescription Use Blood Glucose Meter For Near-Patient Testing","k":"2","r":"862.1345","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":14,"b":0,"e":6,"d":"Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia."},{"c":"PZJ","n":"Lynch Syndrome Test System","k":"2","r":"864.1866","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome"},{"c":"PZK","n":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","k":"3","r":"886.3600","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error."},{"c":"PZL","n":"Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers","k":"2","r":"878.4685","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"Treatment of diabetic foot ulcers"},{"c":"PZM","n":"Next Generation Sequencing Based Tumor Profiling Test","k":"2","r":"866.6080","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing."},{"c":"PZN","n":"Placental Growth Factor Test","k":"N","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"For quantitative determination of Placental Growth Factor (PlGF)."},{"c":"PZO","n":"Software For Visualization Of Vascular Anatomy And Intravascular Devices","k":"2","r":"892.2050","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"Visualization and measurement of blood vessels and intravascular devices for preoperational planning."},{"c":"PZP","n":"Fluid Jet Removal System","k":"2","r":"876.4350","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":9,"b":0,"e":2,"d":"The system is used for removal of prostate tissue with a fluid jet."},{"c":"PZQ","n":"General Laparoscopic Power Morcellation Containment System","k":"2","r":"878.4825","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures."},{"c":"PZR","n":"Percutaneous Nerve Stimulator For Opioid Withdrawal","k":"2","r":"882.5896","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":1,"d":"Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders."},{"c":"PZS","n":"Dual Lumen Ecmo Cannula","k":"2","r":"870.4100","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Long term support greater than 6 hours for acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent."},{"c":"PZT","n":"Peripheral Blood Processing Device For Osteoarthritis","k":"N","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Preparation of autologous anti-inflammatory (AAI) solution from a small sample of peripheral blood for treatment of osteoarthritis."},{"c":"PZU","n":"Bone Marrow Processing Device For Clinical Use","k":"N","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Preparation of concentrated bone marrow aspirate (cBMA) from a sample of bone marrow for clinical use"},{"c":"PZV","n":"Peripheral Blood Processing Device For Clinical Use","k":"N","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Preparation of autologous platelet rich plasma from a small sample of peripheral blood for clinical use"},{"c":"PZW","n":"Catheter Access Cover, Tamper-Resistant","k":"2","r":"880.5970","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter"},{"c":"PZX","n":"Left Atrial Appendage Clip, Implantable","k":"2","r":"878.4300","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Eligible","s":"1","u":"","a":11,"b":0,"e":0,"d":"Intended to occlude the left atrial appendage."},{"c":"PZY","n":"Additively Manufactured, Preformed, Resin Denture Tooth","k":"2","r":"872.3590","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"For the fabrication of preformed denture teeth for use in a denture base"},{"c":"PZZ","n":"Digital Pathology Display","k":"2","r":"864.3700","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The digital pathology display device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from FDA-cleared whole-slide imaging scanners that are used for review and interpretation by trained pathologists."},{"c":"QAA","n":"Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens","k":"2","r":"866.3376","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection."},{"c":"QAB","n":"Pacing System Analyzer","k":"2","r":"870.3605","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads."},{"c":"QAC","n":"Screw Sleeve Bone Fixation Device","k":"2","r":"888.3043","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct."},{"c":"QAD","n":"Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated","k":"2","r":"888.3023","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure."},{"c":"QAF","n":"Impedance Plethysmograph, Cranial","k":"2","r":"870.2770","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Detect or measure variations in volume in the cranium, using tissue impedance properties."},{"c":"QAG","n":"Endoscopic Electrosurgical Clip Cutting System","k":"2","r":"876.4310","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To fragment metallic clips and remove them from the digestive tract."},{"c":"QAI","n":"Powered Microneedle Device","k":"2","r":"878.4430","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":26,"b":0,"e":3,"d":"A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use."},{"c":"QAJ","n":"Cutaneous Electrode Stimulator For Urinary Incontinence","k":"2","r":"876.5330","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence."},{"c":"QAK","n":"Non-Invasive Vagus Nerve Stimulator For Migraine Headache","k":"2","r":"882.5892","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache."},{"c":"QAN","n":"Stent, Iliac Vein","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":6,"e":9,"d":"A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen"},{"c":"QAQ","n":"Adjunctive Predictive Cardiovascular Indicator","k":"2","r":"870.2210","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."},{"c":"QAR","n":"Thermal Vestibular Stimulator For Headache","k":"2","r":"882.5893","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache."},{"c":"QAS","n":"Radiological Computer-Assisted Triage And Notification Software","k":"2","r":"892.2080","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":89,"b":0,"e":0,"d":"Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification ."},{"c":"QAT","n":"Brain Trauma Assessment Test","k":"2","r":"866.5830","p":"IM","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care"},{"c":"QAU","n":"Hemostatic Device For Endoscopic Gastrointestinal Use","k":"2","r":"878.4456","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":8,"d":"Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means."},{"c":"QAV","n":"High Flow/High Velocity Humidified Oxygen Delivery Device","k":"2","r":"868.5454","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"Intended to deliver high flow and/or high velocity oxygen with humidification."},{"c":"QAW","n":"Test, Tricyclic Antidepressants, Over The Counter","k":"2","r":"862.3910","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended to measure any of the tricyclic antidepressant drugs in serum or urine."},{"c":"QAX","n":"Hemodialyzer With Expanded Solute Removal Profile","k":"2","r":"876.5862","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa)."},{"c":"QAZ","n":"Cancer Predisposition Risk Assessment System","k":"2","r":"866.6090","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A qualitative in vitro molecular diagnostic system used for the detection of select variants in specified cancer-related genes. The device is intended to be used on genomic DNA isolated from human specimens collected by the user. The results of the test provide users with a genetic health risk assessment for developing certain cancers. The test may not include all variants associated with a predisposition of developing cancer and is not intended to describe a person’s overall risk of developing any type of cancer nor to aid in determination of treatment or act as a substitute for recommended cancer screenings or appropriate follow-up. The device is for over-the-counter use."},{"c":"QBA","n":"Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"To preserve donor lungs prior to transplantation"},{"c":"QBB","n":"Placental Alpha Microglobulin-1 Immunoassay","k":"3","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor."},{"c":"QBC","n":"External Upper Limb Tremor Stimulator","k":"2","r":"882.5897","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb."},{"c":"QBD","n":"Microbial Nucleic Acid Storage And Stabilization Device","k":"2","r":"866.2950","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":17,"b":0,"e":7,"d":"Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material."},{"c":"QBE","n":"Cranial Sound Monitor","k":"2","r":"870.1875","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To non-invasively detect, monitor, record and display acoustic signals in the brain."},{"c":"QBF","n":"Test, Propoxyphene, Over The Counter","k":"2","r":"862.3700","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The propoxyphene test is an in vitro diagnostic test for the qualitative detection of propoxyphene in human urine. The test is intended for over-the-counter use as the first step in a two step process to provide consumers with information concerning the presence or absence of propoxyphene in a urine sample."},{"c":"QBG","n":"Assay, Oral Direct Thrombin Inhibitor","k":"N","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma"},{"c":"QBH","n":"Lower Respiratory Microbial Nucleic Acid Detection System","k":"2","r":"866.3985","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":4,"d":"Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens."},{"c":"QBI","n":"Acute Coronary Syndrome Event Detector","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention."},{"c":"QBJ","n":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":18,"b":0,"e":23,"d":"An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control."},{"c":"QBK","n":"Meprobamate Test System","k":"2","r":"862.3590","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs)."},{"c":"QBL","n":"Piston Syringe Lever","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Controlled compression of a piston syringe"},{"c":"QBN","n":"Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates","k":"2","r":"866.3378","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections."},{"c":"QBO","n":"Instruments Designed For Press-Fit Osteochondral Implants","k":"2","r":"888.4505","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants."},{"c":"QBP","n":"Cap, Device Disinfectant","k":"2","r":"880.5440","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":22,"b":0,"e":2,"d":"Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time"},{"c":"QBQ","n":"System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture","k":"1","r":"866.2560","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium"},{"c":"QBR","n":"Intranasal Electrostimulation Device For Dry Eye Symptoms","k":"2","r":"886.5310","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only."},{"c":"QBS","n":"Radiological Computer Assisted Detection/Diagnosis Software For Fracture","k":"2","r":"892.2090","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user."},{"c":"QBT","n":"Artificial Iris","k":"3","r":"","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Artificial iris is intended to be implanted to replace the natural iris of the eye."},{"c":"QBV","n":"Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate","k":"1","r":"862.2050","p":"HE","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established."},{"c":"QBW","n":"Surgical Apparel With Material Claims","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Surgical apparel with material claims are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Surgical apparel with material claims contain components that have been constructed, treated, modified, and/or coated with substances that are intended or known to create or enhance a functional element of the device. Examples include fluid repellency, soil retention, or antimicrobial activity."},{"c":"QBX","n":"Direct Blood Bacterial Nucleic Acid Detection System","k":"2","r":"866.3960","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Amplification, detection and identification of microbial pathogens directly from whole blood specimens"},{"c":"QBY","n":"Positive Airway Pressure System","k":"2","r":"868.5273","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface."},{"c":"QBZ","n":"Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma","k":"1","r":"862.2750","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Instrument used to create pools of whole blood, whole blood lysates, serum, and /or plasma, for use in blood donor screening tests. May include sample preparation steps such as lysing of whole blood samples."},{"c":"QCA","n":"Intracranial Coil-Assist Stent","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":2,"d":"An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms."},{"c":"QCB","n":"Phakic Toric Intraocular Lens","k":"3","r":"886.3600","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":5,"d":"Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens."},{"c":"QCC","n":"Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals","k":"2","r":"862.1358","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"An insulin pump therapy adjustment calculator for healthcare professionals is intended to recommend insulin pump therapy parameter adjustments (e.g., basal rate, insulin to carbohydrate ratios, insulin sensitivity factors) based on data from external devices, including continuous glucose monitors."},{"c":"QCD","n":"Continuous Glucose Monitor, Implanted, Adjunctive Use","k":"3","r":"","p":"CH","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices."},{"c":"QCF","n":"Electrical Tongue Stimulator To Treat Motor Deficits","k":"2","r":"882.5889","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits."},{"c":"QCG","n":"Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Intended to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure. These defects may be surgically created from traumatic injury to the bone including bone marrow lesions."},{"c":"QCH","n":"Assayed Quality Control Material For Clinical Microbiology Assays","k":"2","r":"866.3920","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Serologic controls for microbiology assays"},{"c":"QCI","n":"Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder","k":"2","r":"882.5802","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum)."},{"c":"QCJ","n":"Closed Loop Auto Titration Device For Oral Appliances","k":"2","r":"872.5571","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position."},{"c":"QCL","n":"Acid-Sphingomyelinase (Asm) Newborn Screening Test System","k":"2","r":"862.1488","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For quantitative measurement of the activity of acid-sphingomyelinase (ASM) from newborn dried blood spot specimens as an aid in screening newborns for Niemann-Pick disease."},{"c":"QCM","n":"ß-Galactocerebrosidase (Galc) Newborn Screening Test System","k":"2","r":"862.1488","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease."},{"c":"QCR","n":"Wound Autofluorescence Imaging Device","k":"1","r":"878.4165","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information."},{"c":"QCT","n":"Scaffold, Dissection Repair","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries"},{"c":"QCU","n":"Dengue Virus Antigen Assay","k":"2","r":"866.3945","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection"},{"c":"QCW","n":"Corneal Storage Media With Preservatives Including Anti-Fungal","k":"2","r":"886.4320","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Media to preserve human corneas while in storage."},{"c":"QCX","n":"Retrograde Intubation Set","k":"2","r":"868.5095","p":"AN","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800)."},{"c":"QCY","n":"Laser Absorbing Particles","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy."},{"c":"QCZ","n":"Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator","k":"3","r":"","p":"HE","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Intended to enable clinicians to prepare an autologous skin cell suspension for application to burn injuries for use when autografting is indicated for definitive wound closure."},{"c":"QDA","n":"Electrocardiograph Software For Over-The-Counter Use","k":"2","r":"870.2345","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis."},{"c":"QDB","n":"Photoplethysmograph Analysis Software For Over-The-Counter Use","k":"2","r":"870.2790","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis."},{"c":"QDC","n":"Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies","k":"2","r":"866.6100","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings."},{"c":"QDD","n":"Self-Fitting Air-Conduction Hearing Aid, Prescription","k":"2","r":"874.3325","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid."},{"c":"QDF","n":"Parathyroid Autofluorescence Detection Device","k":"2","r":"878.4550","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis."},{"c":"QDG","n":"Parathyroid Autofluorescence Imaging Device","k":"2","r":"878.4550","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis."},{"c":"QDH","n":"Menopause Test System","k":"2","r":"862.1093","p":"CH","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women."},{"c":"QDI","n":"Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies","k":"2","r":"864.1880","p":"PA","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional."},{"c":"QDJ","n":"Direct-To-Consumer Access Pharmacogenetic Assessment System","k":"2","r":"862.3364","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users."},{"c":"QDK","n":"Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes."},{"c":"QDL","n":"Integrated Continuous Glucose Monitoring System For Professional Retrospective Use","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices."},{"c":"QDM","n":"Midazolam Syringe","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended for intramuscular injection of midazolam."},{"c":"QDO","n":"Fentanyl And Other Opioid  Protection Glove","k":"1","r":"880.6250","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs."},{"c":"QDP","n":"Respiratory Panel","k":"2","r":"866.3985","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"The panel is a multiplexed nucleic acid test intended for use with systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection."},{"c":"QDQ","n":"Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer","k":"2","r":"892.2090","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":40,"b":0,"e":0,"d":"A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user."},{"c":"QDR","n":"Plazomicin Test System, Immunoassay","k":"2","r":"862.3460","p":"TX","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"A plazomicin test system is a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary tract infection."},{"c":"QDS","n":"Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System","k":"2","r":"866.4001","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":6,"d":"A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities."},{"c":"QDT","n":"Shoe With Adjustable Sole Units","k":"1","r":"890.3475","p":"PM","g":"Y","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to adjust the foot’s points of contact with the ground to affect the distribution of weight/force(s) applied to a lower limb","x":36},{"c":"QDV","n":"Iol Tray","k":"1","r":"886.4350","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"QDW","n":"Phaco Kit","k":"2","r":"886.4670","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"QDY","n":"Vitrectomy Kit","k":"2","r":"886.4150","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":0,"d":"This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"QDZ","n":"Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection","k":"2","r":"866.3181","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies."},{"c":"QEA","n":"Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid","k":"2","r":"882.1455","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":2,"d":"A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes."},{"c":"QEB","n":"Ventilatory Electrical Impedance Tomograph","k":"2","r":"868.1505","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax."},{"c":"QEC","n":"Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree","k":"2","r":"876.4300","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree"},{"c":"QEF","n":"Pressure Ulcer Management Tool","k":"1","r":"876.2100","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes."},{"c":"QEH","n":"Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections."},{"c":"QEI","n":"Breast Milk Macronutrients Test System","k":"2","r":"862.1493","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"A breast milk macronutrient test system is a device intended to quantitatively measure fat, protein, and total carbohydrate content in human breast milk. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of infants."},{"c":"QEJ","n":"Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries","k":"2","r":"876.4100","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A flushing and storage solution for vascular autografts is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure."},{"c":"QEK","n":"Angiographic Coronary Vascular Physiologic Simulation Software","k":"2","r":"870.1415","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease."},{"c":"QEM","n":"Cerebral Oximeter","k":"2","r":"870.2700","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Oximeter to measure cerebral tissue saturation"},{"c":"QEO","n":"Light Attenuation Lenses For Migraine-Associated Light Sensitivity","k":"1","r":"882.5811","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Light attenuation lenses for migraine-associated light sensitivity are devices that limit light incidence of specific wavelengths to the eyes and are intended to decrease the impact of light sensitivity in patients diagnosed with migraine. The lenses can be mounted on a spectacle frame, clips, or other apertures used to hold lenses. The device is intended to be adjunctive to other therapies for migraine-associated light sensitivity. Sunglasses (nonprescription) and prescription spectacle lenses are separately classified under § 886.5850 and § 886.5844, respectively."},{"c":"QEP","n":"Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections","k":"2","r":"866.3393","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":24,"b":0,"e":4,"d":"A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data."},{"c":"QER","n":"Camera, Ophthalmic, Slit-Scanning","k":"2","r":"886.1120","p":"OP","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area."},{"c":"QES","n":"Reherniation Reduction Device","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc)."},{"c":"QEW","n":"Peripheral Mechanical Thrombectomy With Aspiration","k":"2","r":"870.5150","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":146,"b":0,"e":10,"d":"To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration."},{"c":"QEX","n":"Coronary Mechanical Thrombectomy With Aspiration","k":"2","r":"870.5150","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration."},{"c":"QEY","n":"Mechanical Thrombolysis Catheter","k":"2","r":"870.5150","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":71,"b":0,"e":4,"d":"To mechanically disrupt thrombus and/or debris in the peripheral vasculature."},{"c":"QEZ","n":"Aspiration Thrombectomy Catheter","k":"2","r":"870.5150","p":"CV","g":"Y","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":95,"b":0,"e":0,"d":"To remove thrombus from the peripheral and/or coronary vasculature through aspiration.","x":-1},{"c":"QFA","n":"Assay For Detection Of Proteases In Chronic Wounds","k":"2","r":"866.3231","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A device to detect bacterial protease activity in chronic wound fluid is a lateral flow prescription device that may include a sterile swab. The device is intended for use in patients as an aid in assessing the risk for non-healing of chronic venous, diabetic foot, and pressure ulcers associated with wounds where there are no signs of wound infection and where patient are asymptomatic for clinical signs of infection."},{"c":"QFB","n":"Isocapnic Ventilation Device","k":"2","r":"868.5480","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An isocapnic ventilation device is a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925)."},{"c":"QFC","n":"Negative Pressure Wound Therapy Device For Reduction Of Wound Complications","k":"2","r":"878.4783","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds."},{"c":"QFD","n":"Tens For Sinus Pain","k":"2","r":"882.5890","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Electrical stimulation to relieve pain"},{"c":"QFF","n":"Electromechanical Arm For A Transcranial Magnetic Stimulation System","k":"2","r":"882.5805","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system."},{"c":"QFG","n":"Alternate Controller Enabled Insulin Infusion Pump","k":"2","r":"880.5730","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":30,"b":0,"e":24,"d":"An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery."},{"c":"QFI","n":"Synthetic Next-Generation Sequencing Quality Control And Filler Material","k":"N","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"A synthetic next-generation sequencing filler material which contains an adapter-ligated library which allows users to run partial batches of next-generation sequencing assays by adding the material to sample pools to fill in for incomplete batched runs."},{"c":"QFJ","n":"Intravascular Bleed Monitor","k":"2","r":"870.1345","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications."},{"c":"QFK","n":"Tumor Gene Profiling Test","k":"N","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from nucleic acids isolated from human clinical specimens obtained from patients diagnosed with malignant neoplasms using targeted next-generation sequencing."},{"c":"QFM","n":"Radiological Computer-Assisted Prioritization Software For Lesions","k":"2","r":"892.2080","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":41,"b":0,"e":0,"d":"Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification."},{"c":"QFO","n":"Zika Virus Serological Reagents","k":"2","r":"866.3935","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings."},{"c":"QFP","n":"Intraoperative Orthopedic Strain Sensor","k":"2","r":"888.3090","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making."},{"c":"QFQ","n":"Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss","k":"2","r":"876.5982","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract."},{"c":"QFR","n":"Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties","k":"2","r":"864.5430","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients."},{"c":"QFS","n":"Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis."},{"c":"QFT","n":"Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder","k":"2","r":"882.5803","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) is a software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment."},{"c":"QFV","n":"Implantable Pulse Generator","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"Deliver Cardiac Contractility Modulation signals during the absolute refractory period"},{"c":"QFX","n":"Diagnostic Neurosurgical Microscope Filter","k":"2","r":"882.4950","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition."},{"c":"QFZ","n":"Gastroenterology-Urology Accessories To A Biopsy Instrument","k":"1","r":"876.1080","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas."},{"c":"QGA","n":"Penile Implant Surgical Accessories","k":"1","r":"876.3500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing."},{"c":"QGB","n":"Ureteral Stent Accessories","k":"1","r":"876.4630","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener."},{"c":"QGC","n":"Suprapubic Catheter Accessories","k":"1","r":"876.5100","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath."},{"c":"QGD","n":"Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories","k":"1","r":"876.5290","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing."},{"c":"QGE","n":"Biliary Stent, Drain, And Dilator Accessories","k":"1","r":"876.5012","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube."},{"c":"QGG","n":"Esophageal Sheath With Distal Balloon Anchor","k":"2","r":"876.1510","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device."},{"c":"QGH","n":"Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder","k":"2","r":"882.5940","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition."},{"c":"QGI","n":"Air-Handling Apparatus Accessory","k":"1","r":"878.5080","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches."},{"c":"QGJ","n":"Corneal Inlay Inserter Handle","k":"1","r":"886.4355","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant."},{"c":"QGK","n":"Balloon, Nasal Airway","k":"1","r":"874.4420","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction."},{"c":"QGL","n":"Transcutaneous Nerve Stimulator For Adhd","k":"2","r":"882.5898","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead."},{"c":"QGM","n":"Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation","k":"2","r":"878.4405","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue."},{"c":"QGN","n":"Lateral Flow Immunochromatography Assay For Host Infection Biomarkers","k":"2","r":"866.3230","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings."},{"c":"QGO","n":"Composite Resin Warmer","k":"1","r":"872.6100","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to warm composite materials prior to use"},{"c":"QGP","n":"Posterior Ratcheting Rod System","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"9","a":0,"b":0,"e":0,"d":"Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion."},{"c":"QGQ","n":"Bone Indentation Device","k":"2","r":"888.1600","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A bone indentation device is a device that measures resistance to indentation in bone."},{"c":"QGT","n":"Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine","k":"2","r":"882.5899","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously."},{"c":"QGU","n":"Hemoglobin For Donor Testing","k":"2","r":"864.7500","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Assays hemoglobin concentration test for blood donors."},{"c":"QGX","n":"General Use Pneumatic Tourniquet","k":"1","r":"878.5910","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation."},{"c":"QGY","n":"Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera","k":"2","r":"876.1500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system."},{"c":"QGZ","n":"Electrical Tumor Treatment Fields","k":"3","r":"","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy."},{"c":"QHA","n":"X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device","k":"2","r":"892.1600","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician."},{"c":"QHC","n":"Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs","k":"2","r":"876.1075","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes."},{"c":"QHE","n":"Shoulder Arthroplasty Implantation System","k":"2","r":"888.3660","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":26,"b":0,"e":2,"d":"Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components."},{"c":"QHF","n":"Energy Based Device For Treatment Of Tattoos","k":"2","r":"878.4810","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To reduce formation of bubbles during laser treatment of tattoos"},{"c":"QHG","n":"Defect Measurement Tool","k":"2","r":"888.4510","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device."},{"c":"QHH","n":"Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)","k":"2","r":"876.5340","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain."},{"c":"QHJ","n":"Sensor, Glucose, Implanted, Non-Adjunctive Use","k":"3","r":"","p":"CH","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments."},{"c":"QHM","n":"Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations","k":"U","r":"610.40","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":0,"d":"For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens"},{"c":"QHO","n":"Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations","k":"U","r":"610.40","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":0,"d":"For the qualitative detection of nucleic acid for infectious disease agents in human specimens."},{"c":"QHP","n":"Vertebral Body Tethering System","k":"N","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"9","a":0,"b":0,"e":0,"d":"Anterior-based stabilization or correction of juvenile or adolescent idiopathic scoliosis without the use of fusion"},{"c":"QHQ","n":"Total Shoulder Arthroplasty System","k":"2","r":"888.3660","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"To treat pain and lack of function in the shoulder."},{"c":"QHR","n":"Blood Grouping Reagent","k":"U","r":"660.20","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":1,"d":"For red blood cell antigen typing"},{"c":"QHS","n":"Anti-Human Globulin","k":"U","r":"660.50","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":0,"d":"For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology"},{"c":"QHT","n":"Reagent Red Blood Cells","k":"U","r":"660.30","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":0,"d":"For the detection of or identification of human blood-group antibodies"},{"c":"QHV","n":"Multiple Osteoarticular Pathogen Antigen Kit","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Qualitative detection of microbial antigen in synovial fluid"},{"c":"QHW","n":"Single Lumen Ecmo Cannula","k":"2","r":"870.4100","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent."},{"c":"QHX","n":"Fluoroscopic X-Ray Image Intensifier","k":"1","r":"892.1960","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density."},{"c":"QHY","n":"Solid State Fluoroscopic X-Ray Imager","k":"2","r":"892.1650","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density."},{"c":"QHZ","n":"Seal, Cervical, Mechanical, Unpowered","k":"1","r":"884.1690","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Reduce fluid leakage from the cervix during hysteroscopic procedures."},{"c":"QIA","n":"Powered Tongue Scraper","k":"1","r":"872.6865","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care."},{"c":"QIC","n":"Hiv-1 Genotyping Assay Using Ngs Technology","k":"2","r":"866.3955","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology is a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection."},{"c":"QID","n":"Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens","k":"2","r":"866.4002","p":"MI","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease."},{"c":"QIG","n":"Quality Control Material, Genetics, Rna","k":"2","r":"866.5910","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based controls."},{"c":"QIH","n":"Automated Radiological Image Processing Software","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":338,"b":0,"e":2,"d":"To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code."},{"c":"QII","n":"Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices."},{"c":"QIJ","n":"Endoscopic Transhepatic Venous Access Needle","k":"2","r":"876.1050","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter."},{"c":"QIK","n":"Organ Care System (Ocs) Heart System","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient."},{"c":"QIM","n":"Bartonella Spp. Serological Reagents","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella spp. in patients suspected of exposure."},{"c":"QIN","n":"Babesia Spp. Serological Reagents","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Tests or reagents used to detect IgG and/or IgM antibodies to Babesia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Babesia spp. in patients suspected of exposure."},{"c":"QIO","n":"Anaplasma Spp. And Ehrlichia Spp. Serological Reagents","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Tests or reagents used to detect IgG and/or IgM antibodies to Anaplasma spp. and/or Ehrlichia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Anaplasma spp. and/or Ehrlichia spp. in patients suspected of exposure."},{"c":"QIP","n":"Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure."},{"c":"QIQ","n":"Orientia Spp. (Scrub Typhus) Serological Reagents","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Tests or reagents used to detect IgG and/or IgM antibodies to Orientia spp. (Scrub Typhus) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Orientia spp. in patients suspected of exposure."},{"c":"QIR","n":"Pediatric Hemodialysis System","k":"2","r":"876.5861","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms."},{"c":"QIS","n":"Esophageal, Mucosal, Electrical Characterization","k":"2","r":"876.1450","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue."},{"c":"QIT","n":"Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia","k":"3","r":"","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended to be worn on the surface of the eye in children who have myopia to: • Reduce the rate of progression of myopia, and • Optically correct myopic refractive error."},{"c":"QIU","n":"Intense Pulsed Light Device For Managing Dry Eye","k":"2","r":"886.5201","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye."},{"c":"QIV","n":"Culture-Based Short-Term Incubation Antimicrobial Resistance Assay","k":"2","r":"866.1655","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection."},{"c":"QIX","n":"System, Transdermal Delivery, Cder Or Cber Led","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect."},{"c":"QIY","n":"Nasal Spray, Systemic Delivery, Cder Or Cber Led","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Nasal spray for systemic delivery of drug substance."},{"c":"QIZ","n":"Material, Implantable For Controlled Release, Cder Or Cber Led","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Implantable material for controlled release of drug substance."},{"c":"QJA","n":"Tympanostomy Tube Delivery Product With Drug","k":"3","r":"","p":"EN","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended to place a tympanostomy tube across the tympanic membrane under local anesthesia."},{"c":"QJB","n":"Adjunct Monitor, Protein Calorie Malnutrition","k":"2","r":"870.2770","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters."},{"c":"QJC","n":"Plaque Disclosing Agent","k":"1","r":"872.6855","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to enhance visualization of the presence of plaque on tooth surfaces."},{"c":"QJD","n":"Absorbable Metallic Bone Fixation Fastener","k":"2","r":"888.3041","p":"OR","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved."},{"c":"QJE","n":"Muscular Dystrophy Newborn Screening Test","k":"2","r":"862.1506","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy."},{"c":"QJF","n":"Autofluorescence Imaging Adjunct Tool For Wounds","k":"2","r":"878.4550","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":1,"d":"An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis."},{"c":"QJG","n":"Device System, Imaging, Tympanic Membrane And Middle Ear","k":"2","r":"892.1560","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space."},{"c":"QJH","n":"Reverse Central Venous Recanalization System","k":"2","r":"870.1342","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods."},{"c":"QJI","n":"Interoperable Automated Glycemic Controller","k":"2","r":"862.1356","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":25,"b":0,"e":0,"d":"An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control."},{"c":"QJJ","n":"Indirect Bonding Tray","k":"1","r":"872.5410","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces."},{"c":"QJK","n":"Intraoral Camera","k":"2","r":"872.3661","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"To capture the topographical characteristics of teeth or a stone model"},{"c":"QJL","n":"Splint, Intranasal Septal, Cber Led","k":"1","r":"874.4780","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Splint, Intranasal Septal, CBER led"},{"c":"QJN","n":"Laparoscopic Accessories, Esophageal Sizing","k":"2","r":"876.5360","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ."},{"c":"QJP","n":"Catheter, Percutaneous, Neurovasculature","k":"2","r":"870.1250","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":103,"b":0,"e":7,"d":"To provide vascular access to the neurovasculature for interventional or diagnostic procedures"},{"c":"QJQ","n":"Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety","k":"2","r":"882.5800","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":19,"b":0,"e":1,"d":"To provide electrical current to the head to treat insomnia and/or anxiety"},{"c":"QJR","n":"Reagents, 2019-Novel Coronavirus Nucleic Acid","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":40,"d":"Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens."},{"c":"QJS","n":"Interoperable Automated Glycemic Controller, Insulin Suspend","k":"2","r":"862.1356","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control."},{"c":"QJT","n":"Rigid Sterilization Container With Software","k":"2","r":"880.6855","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems."},{"c":"QJU","n":"Image Acquisition And/Or Optimization Guided By Artificial Intelligence","k":"2","r":"892.2100","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality."},{"c":"QJX","n":"Caries Detection Product With Drug Or Biologic","k":"3","r":"","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic."},{"c":"QJY","n":"Infusion Pump, Drug Specific, Pharmacy-Filled","k":"2","r":"880.5725","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care."},{"c":"QJZ","n":"Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure","k":"2","r":"870.4100","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":2,"d":"Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure."},{"c":"QKA","n":"Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia","k":"2","r":"876.5510","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above."},{"c":"QKB","n":"Radiological Image Processing Software For Radiation Therapy","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":49,"b":0,"e":0,"d":"To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code."},{"c":"QKC","n":"Interactive Rehabilitation Exercise Device, Prescription Use","k":"2","r":"890.5360","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform."},{"c":"QKD","n":"Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use","k":"2","r":"890.5670","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A prescription device to massage irritable, sore trigger points in the pelvic floor musculature to reduce internal pelvic floor trigger point sensitivity."},{"c":"QKE","n":"Immunoassay, Pregnanediol Glucuronide, Over The Counter","k":"1","r":"862.1620","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation"},{"c":"QKF","n":"Immunocytochemistry Assay, P16/Ki-67","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician."},{"c":"QKH","n":"Assisted Reproduction Laminar Flow Workstation","k":"2","r":"884.6120","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is a class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"QKI","n":"Media, Reproductive, Exempt","k":"2","r":"884.6180","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"This product code is the class II exempt counterpart of MQL, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description."},{"c":"QKJ","n":"Stent, Central Venous","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A central venous stent is a prescription device for maintaining the luminal diameter of the central veins."},{"c":"QKL","n":"Lipoaspirate Washing System For Aesthetic Body Contouring","k":"2","r":"878.5040","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation"},{"c":"QKM","n":"A Chemical Vapor Sterilization Multivariable Chemical Indicator","k":"2","r":"880.2800","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process."},{"c":"QKO","n":"Reagent, Coronavirus Serological","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":31,"d":"The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens."},{"c":"QKP","n":"Coronavirus Antigen Detection Test System.","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":47,"d":"The qualitative detection of coronavirus viral antigens directly from clinical specimens."},{"c":"QKQ","n":"Digital Pathology Image Viewing And Management Software","k":"2","r":"864.3700","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":14,"b":0,"e":0,"d":"Digital pathology image viewing and management software device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis."},{"c":"QKR","n":"Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua","k":"N","r":"","p":"HO","g":"Y","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":1,"d":"Face mask is intended to be worn by general public or healthcare personnel and excludes air purifying respirators. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. The device is either subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance, or to the Face Mask Umbrella EUA, available at https://www.fda.gov/media/137121/download"},{"c":"QKS","n":"Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route"},{"c":"QKT","n":"Clozapine Test System","k":"2","r":"862.3245","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens."},{"c":"QKU","n":"Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"For use in healthcare settings by healthcare personnel when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak (see: https://www.fda.gov/media/136403/download) (also see: https://www.fda.gov/media/136664/download). *This excludes NIOSH-approved respirators that are under EUA *This includes authorized KN95s from China under EUA *This excludes KN95s imported under enforcement discretion that don’t have EUA *This includes all authorized non-NIOSH-approved FFRs under EUA"},{"c":"QKV","n":"Electromechanical Tear Stimulator","k":"2","r":"886.5305","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This device type is a non-implantable device intended to increase tear production via mechanical stimulation."},{"c":"QKW","n":"Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis","k":"2","r":"888.3695","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty."},{"c":"QKY","n":"Decontamination Systems For N95 Respirators","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":1,"d":"Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency."},{"c":"QKZ","n":"Magnetically Maneuvered Capsule Endoscopy System","k":"2","r":"876.1310","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction."},{"c":"QLC","n":"Interleukin 6","k":"N","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"In vitro Diagnostic devices for the quantitative determination of IL-6 (interleukin 6) in human specimens"},{"c":"QLD","n":"Protective Barrier Enclosure","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A transparent device designed to cover a patient's head and upper body and incorporates one or more ports through which the HCP's hands are passed to perform medical procedures. Device provides extra layer of barrier protection, in addition to PPE, during the declared public health emergency."},{"c":"QLE","n":"Protective Barrier Enclosure With Negative Pressure","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A barrier device with negative pressure which partially or fully covers a patient to prevent HCP exposure to pathogenic biological airborne particulates. These barrier devices include ports for medical care and/or procedures. Device intended to be used during declared public health emergency."},{"c":"QLF","n":"On-Body Injector","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"","a":0,"b":0,"e":0,"d":"An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs."},{"c":"QLG","n":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":10,"d":"An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems."},{"c":"QLH","n":"System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led","k":"N","r":"","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products"},{"c":"QLI","n":"Vaporizer, Cder Or Cber Led","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Vaporizers are products that vaporize and deliver drug substance to the site of action through inhalation route."},{"c":"QLJ","n":"Patient Monitor With Independent Remote Display And Operation","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Monitors intended for the remote display and operation of patient physiological monitors, including alarm functionality, signal analysis, and data recording during declared public health emergency."},{"c":"QLK","n":"Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain."},{"c":"QLL","n":"Left Ventricular Ejection Fraction Screening Tool","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Electrocardiogram Low Ejection Fraction Tool to be used by healthcare professionals to provide an assessment of Left Ventricular Ejection Fraction (LVEF) for use as a diagnostic aid to screen for potential cardiac complications or underlying cardiac conditions, in adult patients. For use during declared public health emergency."},{"c":"QLM","n":"Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"To be used by healthcare providers in the Intensive Care Unit (ICU) for adult patients for the computation of patient status indices as an adjunct to patient monitoring during the declared public health emergency."},{"c":"QLN","n":"Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19","k":"N","r":"","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":1,"d":"to treat lung failure due to COVID-19 when used as an adjunct to noninvasive or invasive mechanical ventilation in reducing hypercapnia and hypercapnic acidosis due to Coronavirus Disease 2019 (COVID-19), and/or maintaining normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure due to COVID-19 for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved."},{"c":"QLO","n":"Immunoadsorption Column For Emergency Use","k":"N","r":"","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Extracorporeal carbon dioxide removal from blood for use during declared public health emergency."},{"c":"QLQ","n":"Manual Instruments Designed For Use With Total Disc Replacement Devices","k":"2","r":"888.4515","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices."},{"c":"QLR","n":"Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices","k":"2","r":"888.4520","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use."},{"c":"QLT","n":"Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":11,"d":"Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information."},{"c":"QLU","n":"Anti-Factor Xa Activity Test System, Apixaban","k":"2","r":"864.7295","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings."},{"c":"QLV","n":"Field Generator Positioning Device","k":"1","r":"882.4565","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient."},{"c":"QLW","n":"Covid-19 Test Home Collection Kit Devices","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":1,"d":"Specimens collected using the Home Collection Kit can be transported at ambient temperature for testing at a laboratory. SARS-CoV-2 RNA from the clinical specimen is maintained in the specimen packaging and suitable for use in diagnostic testing preformed using a molecular in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 RNA that is authorized for use with the COVID-19 Test Home Collection Kit."},{"c":"QLX","n":"Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna","k":"2","r":"866.3183","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings."},{"c":"QLY","n":"Ophthalmic Syringe","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye."},{"c":"QLZ","n":"Septostomy Catheter, Reprocessed","k":"2","r":"870.5175","p":"CV","g":"Y","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To create or enlarge an atrial septal defect in the heart.","x":-1},{"c":"QMA","n":"Blood Collection Device For Cell-Free Nucleic Acid","k":"2","r":"862.1676","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing."},{"c":"QMC","n":"Transport Medium, Notified Per The Vtm Guidance","k":"1","r":"866.2390","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":4,"d":"Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus)."},{"c":"QMD","n":"Transcranial Magnetic Stimulation System For Smoking Cessation","k":"2","r":"882.5802","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended for use as a transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions."},{"c":"QME","n":"Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate","k":"2","r":"870.2785","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":13,"b":0,"e":0,"d":"The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy."},{"c":"QMF","n":"Mask, Surgical, Eua Authorized","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Surgical masks for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the declared public health emergency. Surgical masks that have been designed, evaluated, and validated consistent with the conditions set forth in FDA's EUA Authorization letter for these devices and that are not excluded from the scope and are not authorized under the EUA."},{"c":"QMG","n":"Shockwave Intravascular Lithotripsy System","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Dilatation of coronary arteries prior to stenting"},{"c":"QMI","n":"Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna","k":"2","r":"866.3183","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions."},{"c":"QMJ","n":"Powered Radiofrequency Toothbrush","k":"2","r":"872.6866","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay."},{"c":"QML","n":"Anal Fistula Closure Device","k":"2","r":"878.4835","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An anal fistula closure device is a surgical implant for anal fistula repair and is intended for closure of the anal fistula. The device may be manually applied or delivered with a delivery device."},{"c":"QMM","n":"Hydrophilic Re-Coating Solution","k":"2","r":"886.5919","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. For prescription use only."},{"c":"QMN","n":"Covid-19 Multi-Analyte Antigen Device","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":7,"d":"A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information."},{"c":"QMS","n":"Adjunctive Open Loop Fluid Therapy Recommender","k":"2","r":"870.5600","p":"CV","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."},{"c":"QMT","n":"Prep Kit – Vaccine Injection","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"","a":0,"b":0,"e":1,"d":"This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance."},{"c":"QMV","n":"Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness","k":"2","r":"866.3966","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors."},{"c":"QMW","n":"Coronary Artery Disease Risk Indicator From Acoustic Heart Signals","k":"2","r":"870.1420","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis."},{"c":"QMX","n":"Label Or Tag, Non-Sterile","k":"1","r":"878.4800","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The device is intended to assist with identification of an IV infusion line used to administer fluids and/or drug products."},{"c":"QMY","n":"Computerized Behavioral Therapy Device For Treating Symptoms","k":"2","r":"876.5960","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions."},{"c":"QMZ","n":"Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions","k":"2","r":"882.5705","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post traumatic stress disorder (PTSD)."},{"c":"QNA","n":"Ultrasonic Urinary Stone Propulsion Device","k":"2","r":"876.4690","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage."},{"c":"QNB","n":"Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein","k":"F","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia."},{"c":"QNC","n":"Whole Exome Sequencing Constituent Device","k":"2","r":"866.6000","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device."},{"c":"QNE","n":"Endoscopic Pancreatic Debridement Device","k":"2","r":"876.4330","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity."},{"c":"QNF","n":"Laser Activator For Polymerization","k":"2","r":"872.6070","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended to polymerize dental restorative resins"},{"c":"QNH","n":"Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":0,"d":"The DNA Mismatch Repair Protein Antibody is a qualitative immunohistochemical antibody intended for the assessment of mismatch repair (MMR) proteins in human clinical tissue specimens. The DNA Mismatch Repair Protein Antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"QNI","n":"Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair","k":"2","r":"888.3044","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL."},{"c":"QNJ","n":"Mass Spectrometry, Microorganism Identification, Blood Culture","k":"2","r":"866.3378","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry."},{"c":"QNK","n":"Optoacoustic Imaging System","k":"3","r":"","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis"},{"c":"QNL","n":"Medium-Term Adjunctive Predictive Cardiovascular Indicator","k":"2","r":"870.2210","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."},{"c":"QNM","n":"Mountable Electromechanical Surgical System For Transluminal Approaches","k":"2","r":"878.4961","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm."},{"c":"QNN","n":"Prosthesis, Total Talus Replacement, Metal","k":"F","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Replaces the native talus"},{"c":"QNO","n":"Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea","k":"2","r":"872.5575","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea."},{"c":"QNP","n":"Gastrointesinal Lesion Software Detection System","k":"2","r":"876.1520","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":23,"b":0,"e":0,"d":"A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope."},{"c":"QNQ","n":"Low Dead Space Piston Syringe","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient."},{"c":"QNR","n":"Blood Pump For Ecmo, Long-Term (> 6 Hours) Use","k":"2","r":"870.4100","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":2,"d":"A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent."},{"c":"QNS","n":"Low Dead Space Needle, Single Lumen, Hypodermic","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient."},{"c":"QNU","n":"Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion","k":"2","r":"874.6000","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion."},{"c":"QNV","n":"Adjunctive Hemodynamic Indicator With Decision Point","k":"2","r":"870.2220","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information."},{"c":"QNW","n":"Reprocessed Bronchoscope","k":"2","r":"874.4680","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission."},{"c":"QNX","n":"External Compression Device For Internal Jugular Vein Compression","k":"2","r":"890.3050","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use."},{"c":"QNY","n":"Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"To be used by healthcare professionals (HCP) in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment with drugs that can prolong QT intervals and may cause life threatening arrhythmias. Device used during declared public health emergency."},{"c":"QNZ","n":"Powered Communication System For Emergency Use","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency."},{"c":"QOA","n":"Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"PPG sensor wearable device used in conjunction with thermometers to triage asymptomatic individuals for COVID-19 risk in settings where thermometers are being used for such purpose in accordance with CDC and institutional infection prevention and control guidelines"},{"c":"QOC","n":"Temporary Non-Roller Type Left Or Right Heart Support Blood Pump","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Providing temporary partial or full left or right heart circulatory support in addition to other treatments for patient during the declared public health emergency."},{"c":"QOD","n":"Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure","k":"N","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure for patient having cardiopulmonary failure during the declared public health emergency."},{"c":"QOF","n":"Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents","k":"2","r":"866.3981","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":38,"b":0,"e":9,"d":"A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors."},{"c":"QOG","n":"Injection Data Capture Device","k":"2","r":"880.5860","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"An injection data capture device is an electrically-powered/electromechanical accessory that interfaces with reusable or disposable injection devices for the purposes of interpreting, recording and displaying and/or transmitting injection data to a connected application or software."},{"c":"QOH","n":"Extracorporeal System For Carbon Dioxide Removal","k":"2","r":"870.4150","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An extracorporeal system for carbon dioxide removal is a system of devices and accessories that provides assisted extracorporeal carbon dioxide removal from the patient's blood in patients with acute respiratory failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, a gas exchanger, blood pump, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors)."},{"c":"QOI","n":"Intravenous Catheter Force-Activated Separation Device.","k":"2","r":"880.5220","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement."},{"c":"QOJ","n":"Apparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)","k":"N","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Intended to be used for the removal of prosthetic breast implant specimens."},{"c":"QOK","n":"Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate","k":"2","r":"870.2786","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy."},{"c":"QOL","n":"Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser","k":"2","r":"890.5420","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain."},{"c":"QON","n":"Implanted Electrical Device Intended For Treatment Of Fecal Incontinence","k":"3","r":"876.5270","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"Treatment of chronic fecal incontinence"},{"c":"QOO","n":"Ventilator Tubing And Accessories","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Accessories used with non-continuous ventilators (may include Ventilator Tubing Connector, Elbow Connector for Mask, Breathing Attachment devices) for use during declared public health emergency."},{"c":"QOP","n":"Respiratory Humidifier For Emergency Use","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device for use during declared public health emergency."},{"c":"QOQ","n":"Non-Continuous Ventilator For Emergency Use","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing for use during declared public health emergency."},{"c":"QOR","n":"Continuous Ventilator, Minimal Ventilatory Support","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency."},{"c":"QOS","n":"Continuous Ventilator","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":1,"d":"Intended to provide continuous ventilatory support for use during declared public health emergency. May be used in hospital or facility settings."},{"c":"QOT","n":"Emergency Ventilator","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency."},{"c":"QOU","n":"Emergency Resuscitator","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Emergency ventilator incorporating bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway (may be automated) for use during declared public health emergency."},{"c":"QOV","n":"Critical Care Ventilator","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas during emergency and/or transfer use. Device is intended to be used temporarily and/or in emergency situations during declared public health emergency."},{"c":"QOW","n":"Ventilatory Assistance Helmet","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"6","a":0,"b":0,"e":0,"d":"Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases."},{"c":"QOX","n":"Multi-Patient Circuit Connector","k":"N","r":"","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Accessory to single patient ventilator to allow multi-patient ventilation during declared public health emergency"},{"c":"QOZ","n":"Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance."},{"c":"QPB","n":"System, Suction, Lipoplasty For Removal","k":"2","r":"878.5040","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":60,"b":0,"e":1,"d":"A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring"},{"c":"QPC","n":"Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":12,"b":0,"e":0,"d":"A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded."},{"c":"QPD","n":"Personal Lubricant Ring","k":"2","r":"884.5300","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, polyurethane, and/or internal condoms."},{"c":"QPE","n":"Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions","k":"2","r":"878.4880","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics."},{"c":"QPF","n":"Pediatric Autism Spectrum Disorder Diagnosis Aid","k":"2","r":"882.1491","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":7,"b":0,"e":0,"d":"A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients."},{"c":"QPK","n":"Eua Faceshields","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"11","a":0,"b":0,"e":0,"d":"Authorized faceshields intended for use during the declared public health emergency."},{"c":"QPL","n":"Electromagnetic Stimulator, Pain Relief","k":"2","r":"882.5890","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Intended to apply a magnetic-field induced electrical current to treat pain."},{"c":"QPN","n":"Software Algorithm Device To Assist Users In Digital Pathology","k":"2","r":"864.3750","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis."},{"c":"QPO","n":"Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples","k":"2","r":"866.2952","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":6,"d":"A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms."},{"c":"QPP","n":"Implantable Post-Surgical Kinematic Measurement Knee Device","k":"2","r":"888.3600","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":1,"d":"An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery."},{"c":"QPQ","n":"Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable,  Non-Fixed","k":"2","r":"888.3630","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears."},{"c":"QPR","n":"Neurological Stimulation For Emergency Use","k":"N","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"authorized nerve stimulation devices for respiratory assistance for use during declared public health emergency use."},{"c":"QPS","n":"Immunoassay For Host Biomarkers Of Infection","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens."},{"c":"QPT","n":"Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence","k":"3","r":"","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve."},{"c":"QPW","n":"Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube","k":"N","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"A blood collection tube intended for emergency use in healthcare settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19."},{"c":"QPX","n":"Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical","k":"2","r":"878.4683","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts."},{"c":"QPY","n":"Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation","k":"3","r":"","p":"PM","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Stimulation of the vagus nerve"},{"c":"QPZ","n":"Contact Cooling For Skin Lesion Pain Relief","k":"2","r":"878.4340","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures."},{"c":"QQB","n":"Prognostic Test For Assessment Of Liver Related Disease Progression","k":"2","r":"862.1622","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses."},{"c":"QQC","n":"Brain Stimulation Programming Planning Software.","k":"2","r":"882.5855","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators."},{"c":"QQE","n":"Image Management Software For Planning Of Otologic And Neurotologic Procedures","k":"2","r":"892.2050","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures."},{"c":"QQF","n":"Skin Microneedling Manual/Automated Device (Export Only)","k":"N","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"For one-time (1X) use by qualified clinical professionals to cause bio-active effect(s) in skin for aesthetic improvement."},{"c":"QQG","n":"Oropharyngeal Electrical Stimulator","k":"2","r":"874.5950","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube."},{"c":"QQH","n":"Powered Insertion System For A Cochlear Implant Electrode Array","k":"2","r":"874.4450","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea."},{"c":"QQI","n":"Interventional Cardiovascular Implant Simulation Software Device","k":"2","r":"870.1405","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment."},{"c":"QQJ","n":"Applicator, Negative Pressure, External, Ocular","k":"2","r":"886.5000","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients."},{"c":"QQK","n":"Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation","k":"3","r":"","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":1,"d":"The device is intended for machine preservation of donor livers prior to transplantation."},{"c":"QQO","n":"Cranial Measurement Software","k":"1","r":"878.4800","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods."},{"c":"QQQ","n":"Guide And Positioner, Ophthalmic Drug Delivery Device","k":"1","r":"886.4300","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"","a":0,"b":0,"e":0,"d":"To provide a guide and/or positioner for filling of a drug delivery device."},{"c":"QQR","n":"Circumcision Device With Stapler","k":"2","r":"884.4530","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"To cut and suture / staple the prepuce."},{"c":"QQS","n":"Stapler, Skin","k":"1","r":"878.4740","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery."},{"c":"QQT","n":"Immunohistochemistry Assay, Antibody, Ki-67","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"QQU","n":"Digital Therapy Device For Amblyopia","k":"2","r":"886.5500","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia."},{"c":"QQV","n":"Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry","k":"2","r":"866.3378","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS)."},{"c":"QQX","n":"Respiratory Specimen Nucleic Acid Sars-Cov-2 Test","k":"2","r":"866.3981","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":11,"b":0,"e":0,"d":"A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors."},{"c":"QQY","n":"Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms","k":"2","r":"866.2190","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media."},{"c":"QRA","n":"Virtual Reality Behavioral Therapy Device For Pain Relief","k":"2","r":"890.5800","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":1,"d":"A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display which utilizes a software program containing the behavioral therapy content."},{"c":"QRB","n":"Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"To relieve pain in patients with diabetic neuropathy"},{"c":"QRC","n":"Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation","k":"2","r":"876.5026","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves."},{"c":"QRF","n":"Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer","k":"3","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":2,"d":"Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy."},{"c":"QRG","n":"Ultrasound Guided Nerve Block Assist","k":"2","r":"868.1980","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia."},{"c":"QRH","n":"Catheter, Balloon, Urethral, Drug-Coated","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Dilate urethral strictures"},{"c":"QRI","n":"Surgical Planning Software For Neurological Stereotaxic Instruments","k":"2","r":"882.4560","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A surgical planning software for neurological stereotaxic instruments is intended as a stand-alone software device used for pre- and intra-operative planning of stereotactic or image-guided surgeries."},{"c":"QRJ","n":"Laser-Powered Inferior Vena Cava Filter Retrieval Catheter","k":"2","r":"870.5125","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A laser-powered inferior vena cava (IVC) filter retrieval catheter is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate in the detachment and removal of indwelling IVC filters."},{"c":"QRK","n":"Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature","k":"2","r":"878.4850","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":17,"b":0,"e":0,"d":"A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes."},{"c":"QRL","n":"Multiple Use Blood Lancet For Single Patient Use Only","k":"2","r":"878.4850","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":27,"b":0,"e":1,"d":"A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes."},{"c":"QRM","n":"Multiple Use Blood Lancet For Multiple Patient Use","k":"3","r":"878.4850","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes."},{"c":"QRN","n":"Radiation Therapy Marking Device","k":"2","r":"892.5785","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses."},{"c":"QRQ","n":"Non-Irrigation Endosseous Dental Implant Drill Bits","k":"1","r":"872.3980","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation."},{"c":"QRR","n":"Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside","k":"2","r":"888.3046","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection."},{"c":"QRS","n":"Device For Sleep Apnea Testing Based On Mandibular Movement","k":"2","r":"868.2376","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A device for sleep apnea testing based on mandibular movement is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders by analyzing sensor readings of mandibular movement. The device is not intended as a substitute for full polysomnography nor intended to be used as an apnea monitor."},{"c":"QRU","n":"Implant, Resorbable, For Articular Osteochondral Repair","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"This device is intended to repair knee joint surface cartilage or osteochondral lesions."},{"c":"QRV","n":"Setmelanotide Eligibility Gene Variant Detection System","k":"2","r":"862.1164","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A setmelanotide eligibility gene variant detection system is a qualitative in vitro diagnostic device intended to detect germline variants within genes isolated from human specimens for the purpose of identifying patients with obesity who may benefit from treatment with setmelanotide in accordance with the approved therapeutic product labeling."},{"c":"QRX","n":"Continuous Glucose Monitor Informed Insulin Dose Calculator","k":"2","r":"862.1358","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":2,"d":"A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information."},{"c":"QRY","n":"Dental Navigation System","k":"2","r":"872.4120","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":3,"d":"Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures."},{"c":"QRZ","n":"External Condom For Anal Intercourse Or Vaginal Intercourse","k":"2","r":"884.5305","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An external condom for anal intercourse or vaginal intercourse is a barrier device which covers the penis and is used to prevent the transmission of sexually transmitted infections (when used for anal intercourse or vaginal intercourse) and for contraception (when used for vaginal intercourse). This classification does not include condoms intended for vaginal intercourse only."},{"c":"QSA","n":"Circulating Tumor Cell (Ctc) Enrichment Device","k":"2","r":"866.6110","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing."},{"c":"QSB","n":"Orthosis, Truncal, Pregnancy","k":"1","r":"890.3490","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Provide abdominal and back support during pregnancy"},{"c":"QSD","n":"Posterior Cervical Screw Placement Guide","k":"2","r":"888.3075","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans."},{"c":"QSE","n":"Alzheimer’S Disease Pathology Assessment Test","k":"2","r":"866.5840","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents."},{"c":"QSF","n":"Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents","k":"3","r":"","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only."},{"c":"QSH","n":"Coronavirus Marker Detection","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Coronavirus marker detection"},{"c":"QSK","n":"Hybrid Stent Graft, Thoracic Aortic Lesion Treatment","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair."},{"c":"QSL","n":"Brain Temperature Measurement System","k":"2","r":"882.1565","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature."},{"c":"QSM","n":"System, Surgical, Computer Controlled Instrument, Remanufactured","k":"2","r":"876.1500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"As intended with the originally cleared instrument."},{"c":"QSN","n":"Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System","k":"2","r":"866.3988","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections."},{"c":"QSO","n":"Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs","k":"2","r":"878.4040","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs."},{"c":"QSQ","n":"Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms","k":"2","r":"882.5888","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms."},{"c":"QSR","n":"Sacroiliac Screw Placement Guide","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A sacroiliac screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of sacroiliac screws across the sacroiliac joint. The device utilizes anatomical landmarks that are identifiable on pre-operative imaging scans."},{"c":"QSS","n":"Hiv Self-Tests","k":"3","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids."},{"c":"QST","n":"Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test","k":"2","r":"866.3957","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues."},{"c":"QSU","n":"Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test","k":"2","r":"866.3956","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Human immunodeficiency virus (HIV) Point of Care serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues."},{"c":"QSV","n":"Point Of Care Hiv Nat Diagnostic And/Or Supplemental Test","k":"2","r":"866.3957","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Human immunodeficiency virus (HIV) Point of Care nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues."},{"c":"QSW","n":"Endoscopic Traction Device","k":"2","r":"876.4410","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal."},{"c":"QSX","n":"Hemostatic Wound Dressing With Thrombin Or Other Biologics","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":18,"b":0,"e":0,"d":"To temporarily control bleeding and cover external wounds."},{"c":"QSY","n":"Hemostatic Wound Dressing Without Thrombin Or Other Biologics","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":127,"b":0,"e":0,"d":"To temporarily control bleeding and cover external wounds."},{"c":"QSZ","n":"Absorbable Synthetic Wound Dressing","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":22,"b":0,"e":0,"d":"Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application."},{"c":"QTA","n":"Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"This is an IVD test which utilizes a next generation sequencing (NGS) method performed on a high throughput sequencing platform. This test can identify and differentiate SARS-CoV-2 and support additional genetic analysis, when clinically indicated, from SARS-CoV-2-positive samples identified as positive using an EUA authorized diagnostic test. Testing is limited to designated laboratories."},{"c":"QTB","n":"Nitric Oxide Generator And Delivery System","k":"3","r":"","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2)."},{"c":"QTC","n":"Adult Portable Bed Rails For Medical Purposes","k":"1","r":"890.5050","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":2,"d":"An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics."},{"c":"QTD","n":"Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss","k":"2","r":"876.5983","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss."},{"c":"QTE","n":"Thymidine Kinase Activity","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients."},{"c":"QTF","n":"Reprocessed Atherectomy Catheter","k":"2","r":"870.4875","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":8,"d":"Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission"},{"c":"QTG","n":"Infant Supine Sleep System","k":"2","r":"880.5690","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":3,"d":"An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID)."},{"c":"QTH","n":"Endoscopic Light-Projecting Measuring Device","k":"2","r":"876.1530","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest."},{"c":"QTI","n":"Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs."},{"c":"QTK","n":"Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device","k":"F","r":"","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Used to temporarily dilate and increase the diameter of cerebral arteries experiencing symptomatic vasospasm"},{"c":"QTM","n":"Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.","k":"2","r":"866.3920","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening."},{"c":"QTN","n":"Orally Ingested Transient Device For Constipation","k":"2","r":"876.5940","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation."},{"c":"QTO","n":"Digital Visual Acuity Test","k":"1","r":"886.1150","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients."},{"c":"QTP","n":"Reagents, Monkeypox Virus Nucleic Acid.","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Nucleic acid-based in vitro diagnostic devices for the detection of monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens"},{"c":"QTQ","n":"Reagents, Non-Variola Orthopoxvirus Nucleic Acid.","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Nucleic acid-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus and/or diagnosis of Monkeypox in human clinical specimens."},{"c":"QTT","n":"Over The Counter Electrical Salivary Stimulatory System","k":"2","r":"872.5560","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Over the Counter Device intended to electrically stimulate a relative increase in saliva production"},{"c":"QTU","n":"Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"3","a":0,"b":0,"e":0,"d":"Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY"},{"c":"QTV","n":"Mattress And Bed Deck Cover (Medical Purposes)","k":"1","r":"880.6190","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame."},{"c":"QTW","n":"Digital Amsler Grid","k":"1","r":"886.1330","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients."},{"c":"QTY","n":"Von Willebrand Factor Assay","k":"2","r":"864.7293","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A von Willebrand factor assay is a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma."},{"c":"QTZ","n":"Radiological Image Processing Software For Ablation Therapy Planning And Evaluation","k":"2","r":"892.2050","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy."},{"c":"QUA","n":"Intraoral Cooling Device","k":"2","r":"872.5590","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces"},{"c":"QUB","n":"Suction Lipoplasty System For Removal And Transfer","k":"2","r":"878.5040","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring"},{"c":"QUD","n":"Blood Detection Capsule","k":"2","r":"876.1390","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Ingestible gastrointestinal blood detection capsule device is a prescription device that uses spectrophotometry (light absorption technology) to detect the presence or absence of blood in the gastrointestinal tract."},{"c":"QUE","n":"Spinal Muscular Atrophy Newborn Screening Test System","k":"2","r":"866.5980","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing."},{"c":"QUF","n":"Hearing Aid, Air-Conduction, Over The Counter","k":"1","r":"874.3300","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf."},{"c":"QUG","n":"Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter","k":"2","r":"874.3305","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":1,"d":"A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf."},{"c":"QUH","n":"Self-Fitting Air-Conduction Hearing Aid, Over The Counter","k":"2","r":"874.3325","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf."},{"c":"QUJ","n":"Automated Cryopreservation Storage System","k":"2","r":"884.6120","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm."},{"c":"QUK","n":"Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test","k":"2","r":"866.5960","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A Human Leukocyte Antigen (HLA) Typing Companion Diagnostic (CDx) Test is a prescription genotyping or phenotyping assay intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product, or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product."},{"c":"QUL","n":"Immunohistochemistry Assay, Antibody, Folr1","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The FOLR1 antibody is a qualitative immunohistochemical antibody intended to identify FOLR1 protein expression in human clinical tissue specimens. The FOLR-1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"QUM","n":"Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test","k":"2","r":"866.3958","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A human immunodeficiency virus (HIV) viral load monitoring test is an in vitro diagnostic prescription device for the quantitation of the amount of HIV ribonucleic acid (RNA) in human body fluids"},{"c":"QUN","n":"Tether Accessory For Use In The Gastrointestinal Tract","k":"2","r":"876.1305","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract."},{"c":"QUO","n":"Adjunctive Heart Failure Status Indicator","k":"2","r":"870.2200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."},{"c":"QUQ","n":"Knife, Intraocular Pressure Lowering","k":"2","r":"878.4400","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma"},{"c":"QUR","n":"Prescription Spectacle Lenses To Reduce The Progression Of Myopia","k":"2","r":"886.5845","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under § 886.5842."},{"c":"QUT","n":"Deformability Cytometry For Sepsis Risk Assessment","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis"},{"c":"QUU","n":"Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples","k":"2","r":"866.3046","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus."},{"c":"QUV","n":"Phase-Changing Fiducial Marker For Radiation Therapy","k":"2","r":"892.5727","p":"RA","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities."},{"c":"QUW","n":"Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament","k":"2","r":"878.3300","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair."},{"c":"QVA","n":"Fludeoxyglucose F18-Guided Radiation Therapy System","k":"2","r":"892.5060","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":3,"d":"A fludeoxyglucose F18-guided radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator."},{"c":"QVB","n":"Biological Sterilization Indicator With Indirect Growth Detection","k":"2","r":"880.2806","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products."},{"c":"QVC","n":"Ventilator Waveform Analysis Software","k":"2","r":"868.5896","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Ventilator waveform analysis software is a prescription device that uses software algorithms to analyze mechanical ventilation waveform data to detect, display, and summarize patient-ventilator interactions. The device provides results to healthcare providers as an aid to monitoring or clinical assessment."},{"c":"QVD","n":"Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan","k":"2","r":"892.2055","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan."},{"c":"QVE","n":"Adjunctive Pain Measurement Device For Anesthesiology","k":"2","r":"868.2200","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making."},{"c":"QVF","n":"Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings","k":"2","r":"866.3982","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":10,"b":0,"e":0,"d":"A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory"},{"c":"QVG","n":"Embolization Agent, Vascular","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"For occluding peripheral vessels"},{"c":"QVI","n":"Screw Sleeve Bone Fixation Device, Spine","k":"2","r":"888.3043","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct."},{"c":"QVJ","n":"Low Power Electrosurgical Devices For Skin Lesion Destruction","k":"2","r":"878.4400","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions"},{"c":"QVL","n":"Absorbable Gel For Intraoperative Use In Spine Surgery","k":"2","r":"888.3047","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms."},{"c":"QVN","n":"Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus","k":"2","r":"874.3410","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus."},{"c":"QVO","n":"Computerized Behavioral Therapy Device For Insomnia","k":"2","r":"882.5801","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The device is intended to provide cognitive behavioral therapy to treat insomnia."},{"c":"QVP","n":"Sars-Cov-2 Serology Test","k":"2","r":"866.3983","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors."},{"c":"QVQ","n":"Extravascular Support For An Arteriovenous Fistula For Vascular Access","k":"2","r":"870.4600","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This device is a permanent implant which is surgically placed outside and/or around an artery and/or vein to provide external support to arteriovenous fistulas created for vascular access by means of vascular surgery."},{"c":"QVR","n":"Multiplex Nucleic Acid Detection System For Biothreat Agents","k":"2","r":"866.4000","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens"},{"c":"QVS","n":"Breast Implant Suction Retrieval Device","k":"2","r":"878.4675","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A breast implant suction retrieval system is a prescription surgical device that uses vacuum suction to assist in the removal and containment of a ruptured silicone breast implant."},{"c":"QVT","n":"Monitor For Opioid Induced Impairment Of Oxygenation","k":"2","r":"868.2250","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose"},{"c":"QVU","n":"High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.","k":"2","r":"866.6095","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only."},{"c":"QVV","n":"Medial Knee Implanted Shock Absorber","k":"2","r":"888.3610","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee."},{"c":"QVW","n":"Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led","k":"N","r":"","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"4","a":0,"b":0,"e":0,"d":"Generator, measurement, and/or delivery system for hyperpolarized MR imaging agents, and accessories, are devices that generate a hyperpolarized MR imaging agent, monitor the dose equivalent volume of the dispensed dose, and/or store, transport or administer the imaging agent to the patient"},{"c":"QVX","n":"Skin Patch For Treatment Of Hyperhidrosis","k":"2","r":"878.4425","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis."},{"c":"QVY","n":"Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome","k":"2","r":"880.5151","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Reusable hospital mattress pad with integrated mechanical vibrations to be used as adjunctive therapy for neonates and infants with neonatal abstinence syndrome (NAS) or neonatal opioid withdrawal syndrome (NOWS)."},{"c":"QWA","n":"Cardiovascular Delivery Catheter System Positioning And Stabilization Device","k":"1","r":"870.3955","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable."},{"c":"QWB","n":"Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens","k":"2","r":"866.3984","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":1,"d":"An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments."},{"c":"QWC","n":"Pulmonary Stent","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A pulmonary stent is a metal scaffold placed via a delivery catheter into the pulmonary artery to maintain the lumen."},{"c":"QWD","n":"Stimulator, Nerve, For Restless Legs Syndrome","k":"2","r":"882.5887","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome."},{"c":"QWE","n":"Hyperoxia Monitoring Device Adjunct To Pulse Oximetry","k":"2","r":"870.2720","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring."},{"c":"QWF","n":"Tubing, Long Term Support Greater Than 6 Hours","k":"2","r":"870.4100","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours."},{"c":"QWH","n":"Prognostic Test For Development Or Progression Of Preeclampsia","k":"2","r":"862.1602","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease."},{"c":"QWI","n":"Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms","k":"2","r":"882.5804","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms"},{"c":"QWJ","n":"Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament","k":"2","r":"878.3300","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For reinforcement of soft tissue where weakness exists in ligament repair"},{"c":"QWK","n":"Prosthesis, Posterior Spinal Elements","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements."},{"c":"QWL","n":"Intraoperative Surgical Angle Measurement Tool","k":"2","r":"888.4560","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy."},{"c":"QWM","n":"Stent Graft, Bypass, Superficial Femoral Artery","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"For bypassing stenosis in the superficial femoral artery via the femoral vein"},{"c":"QWN","n":"Stent Graft, Infrapopliteal, Venous Arterialization","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"For performing percutaneous arterialization of the deep veins to restore blood flow in the lower limbs"},{"c":"QWO","n":"Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.","k":"2","r":"892.2085","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process."},{"c":"QWP","n":"Optical Neurosurgical Nerve Locator","k":"2","r":"874.1820","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery."},{"c":"QWQ","n":"Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors","k":"3","r":"","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"An in vitro diagnostic device intended to detect and/or measure pre-existing endogenous antibodies to adeno-associated virus (AAV) viral vectors in patients who may receive AAV vector-based gene therapy products."},{"c":"QWR","n":"Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings","k":"2","r":"866.3982","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory."},{"c":"QWS","n":"Foam Or Gel Chemical Sterilant/High Level Disinfectant","k":"2","r":"880.6886","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use."},{"c":"QWT","n":"Prognostic Assessment Software Of Mild Cognitive Impairment","k":"2","r":"882.1454","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic too."},{"c":"QWU","n":"Prosthesis, Eyelid Spacer/Graft, Polymer","k":"2","r":"886.3130","p":"OP","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":3,"d":"For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area."},{"c":"QWW","n":"Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.","k":"2","r":"876.5021","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Eligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection."},{"c":"QWX","n":"Active Noise Attenuation System For Infant Incubators","k":"2","r":"880.5405","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment."},{"c":"QWY","n":"Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator","k":"3","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":0,"e":0,"d":"Intended for use at the patient’s point of care by clinicians to prepare an autologous skin cell suspension for application to prepared treatment areas indicated for repigmentation in patients with stable vitiligo."},{"c":"QWZ","n":"Prognostic Test For Assessment Of Chronic Kidney Disease Progression","k":"2","r":"862.1223","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":3,"d":"A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product."},{"c":"QXA","n":"Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection","k":"2","r":"866.3230","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings."},{"c":"QXB","n":"Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia"},{"c":"QXC","n":"Diabetes Digital Therapeutic Device","k":"2","r":"880.5735","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication."},{"c":"QXD","n":"Spinal Imaging System For Neuraxial Procedures","k":"2","r":"868.1985","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures."},{"c":"QXG","n":"Cooperative Powered Surgical Assist Device For Ent Surgery","k":"2","r":"874.4460","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument."},{"c":"QXH","n":"Gallbladder Drainage Stent And Delivery System","k":"2","r":"876.5016","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system."},{"c":"QXJ","n":"Whole Room Microbial Reduction Device","k":"2","r":"880.6510","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection."},{"c":"QXL","n":"Cabinet, Emission Computed Tomography System","k":"2","r":"892.1200","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures"},{"c":"QXM","n":"Implanted Tibial Electrical Urinary Continence Device","k":"2","r":"876.5305","p":"GU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia."},{"c":"QXN","n":"Suction Anti-Choking Device As A Second-Line Treatment","k":"2","r":"874.5400","p":"EN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A suction anti-choking device as a second-line treatment is intended to be used, by application of suction, to resolve choking in victims experiencing complete airway obstruction. The device is intended to be used as a second-line treatment in an emergency situation after unsuccessful use of a basic life support (BLS) choking protocol."},{"c":"QXO","n":"Cardiovascular Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias."},{"c":"QXQ","n":"Respiratory Accessory Microbial Reduction Device.","k":"2","r":"880.6993","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":2,"d":"A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions."},{"c":"QXR","n":"Vaginal Hydrogel Packing System","k":"2","r":"892.5735","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery."},{"c":"QXS","n":"Chromogranin A","k":"2","r":"866.6010","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors."},{"c":"QXT","n":"Infliximab Test System","k":"2","r":"862.3115","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis."},{"c":"QXU","n":"Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation","k":"2","r":"870.5710","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy"},{"c":"QXV","n":"Temperature Regulation Device For Esophageal Protection During Cardiac Ablation","k":"2","r":"870.5720","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the esophagus during cardiac ablation."},{"c":"QXW","n":"Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer","k":"2","r":"878.4355","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A cryoablation device for local treatment of low-risk breast cancer is a prescription device that uses cold temperatures to destroy a breast tumor and its surrounding tissue. The device is intended as a local treatment and may be used with adjuvant therapies (e.g., endocrine therapy, radiation therapy) to reduce the risk of local disease progression. The device is intended for use in patients with a well-defined solid tumor (e.g., invasive ductal carcinoma) and with low risk of recurrence and metastasis, as determined by clinical risk factors consistent with the indications for use. The device is not intended to treat breast cancers with high risk of local recurrence (e.g., lobular carcinoma), patients with aggressive forms of breast cancer (e.g., breast cancers with inflammatory features), or patients in whom targeted systemic therapy is indicated."},{"c":"QXX","n":"Coronary Artery Disease Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up."},{"c":"QXY","n":"Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature","k":"2","r":"870.1135","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user."},{"c":"QXZ","n":"Adjunctive Epicardial Vascular Physiologic Status Indicator","k":"2","r":"870.2200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy."},{"c":"QYA","n":"System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home","k":"2","r":"866.3385","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"This device is an in vitro diagnostic system intended for self-collecting specimens in home settings or similar environments and testing in a clinical laboratory for detection of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections. The device is intended to aid in the diagnosis of sexually transmitted infections. The device is intended for prescription use or over-the-counter use."},{"c":"QYC","n":"Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions","k":"2","r":"864.9115","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment."},{"c":"QYD","n":"Adalimumab Assay","k":"2","r":"862.3115","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody"},{"c":"QYE","n":"Reduced Ejection Fraction Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":6,"b":0,"e":0,"d":"Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up."},{"c":"QYF","n":"Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)","k":"2","r":"870.1130","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring."},{"c":"QYI","n":"Ablation Catheter, Renal Denervation","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":2,"d":"For denervating the renal nerves to lower blood pressure"},{"c":"QYJ","n":"Dental Waterline Treatment Cartridge","k":"1","r":"872.6640","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"Intended to reduce microbial bioburden in dental unit water lines"},{"c":"QYK","n":"Semi-Automated Autologous Skin Graft Harvesting And Application Device","k":"2","r":"878.4795","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns."},{"c":"QYM","n":"Ophthalmic Needle","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye."},{"c":"QYN","n":"Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)","k":"1","r":"890.5775","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies"},{"c":"QYO","n":"Hematopoietic Cell Enrichment Kit","k":"2","r":"866.6120","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow."},{"c":"QYQ","n":"Prosthesis, Total Talus Replacement With Soft Tissue Attachment Sites, Metal","k":"F","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Replaces the native talus"},{"c":"QYT","n":"Over-The-Counter Covid-19 Antigen Test","k":"2","r":"866.3984","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":14,"b":0,"e":3,"d":"For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older."},{"c":"QYU","n":"Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use","k":"2","r":"870.2705","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s)."},{"c":"QYV","n":"Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm","k":"2","r":"864.3900","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis."},{"c":"QYW","n":"Hospital Cardiac Telemetry","k":"2","r":"870.1025","p":"CV","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and recording of cardiac electrical activity, automated detection of life-threatening arrhythmias or other relevant conditions, and/or alarm generation. Devices may allow remote access and display of electrocardiograms acquired. Devices are intended for patients who require continuous monitoring in hospitals or healthcare facilities, with onsite medical review by qualified personnel at the central monitoring/analysis station followed by immediate notification of onsite qualified medical responders. Devices may be used for patients at elevated risk of serious cardiovascular events that would require prompt intervention. Devices are intended for prescription use only."},{"c":"QYX","n":"Outpatient Cardiac Telemetry","k":"2","r":"870.1025","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":21,"b":0,"e":0,"d":"Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only."},{"c":"QYZ","n":"At Home Intravaginal Insemination System","k":"2","r":"884.6110","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"To deliver semen to the vaginal canal for insemination."},{"c":"QZA","n":"Body Temperature Sensing Software","k":"2","r":"880.2915","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data."},{"c":"QZB","n":"Software Controlled Endoscope And Instrument Holder","k":"2","r":"876.1500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"To hold and position endoscopes and instruments."},{"c":"QZC","n":"External Mechanical Stimulator For The Relief Of Congestion","k":"2","r":"874.6010","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion."},{"c":"QZF","n":"Gastrointestinal Capsule Endoscopy Analysis Software Device","k":"2","r":"876.1540","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system."},{"c":"QZG","n":"Menstrual Blood Collection Device","k":"2","r":"862.1675","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing"},{"c":"QZH","n":"Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit","k":"3","r":"","p":"TX","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A qualitative in vitro molecular test that detects select variants in genomic DNA isolated from human specimens. Results of the test provide users with a genetic risk assessment of developing Opioid Use Disorder (OUD) and are intended to aid users with informed decision-making regarding the use of oral opioids for acute pain relief. The test may not include all variants associated with a risk of developing OUD and is not intended to describe a person’s overall risk of developing OUD. Results from the system are intended to be used in combination with clinical information and should not be the sole determinant in diagnosing, counseling, or making prescribing decisions"},{"c":"QZI","n":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","k":"3","r":"","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":6,"e":6,"d":"For the treatment of atrial fibrillation."},{"c":"QZJ","n":"Immunohistochemistry Assay, Antibody, Claudin 18","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The Claudin 18 antibody is a qualitative immunohistochemical antibody intended to identify CLDN18 protein expression in human clinical tissue specimens. The CLDN18 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"QZK","n":"Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Endovascular repair of thoracoabdominal and pararenal aortic lesions"},{"c":"QZL","n":"Post-Ablation Tissue Response Prediction Software","k":"2","r":"892.2052","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment."},{"c":"QZN","n":"Multi-Photon Imaging","k":"2","r":"878.4580","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To provide visible illumination of the surgical field or the patient"},{"c":"QZO","n":"Wearable Vibration Device For Orthopedic Use","k":"2","r":"888.5895","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density."},{"c":"QZP","n":"Camera, Ophthalmic, Non-Prescription","k":"2","r":"886.1120","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional."},{"c":"QZS","n":"Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer","k":"2","r":"878.1830","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis."},{"c":"QZT","n":"Gowns And Other Apparel","k":"N","r":"","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"8","u":"11","a":0,"b":0,"e":0,"d":"Gowns and other apparel are authorized under the EUA for use by HCPs in healthcare settings in accordance with CDC recommendations to protect both HCPs and patients from the transfer of SARS-CoV-2 in low or minimal risk level situations to prevent the spread of COVID-19."},{"c":"QZU","n":"Temporary Embolization Assist Device, Peripheral","k":"2","r":"870.3325","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed."},{"c":"QZV","n":"Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury","k":"3","r":"","p":"HE","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"For the treatment of acute kidney injury in pediatric patients, in conjunction with continuous kidney replacement treatment (CKRT)."},{"c":"QZW","n":"Over-The-Counter Device To Assess Risk Of Sleep Apnea","k":"2","r":"868.2378","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor."},{"c":"QZX","n":"Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing","k":"2","r":"866.1650","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing."},{"c":"QZY","n":"Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating","k":"2","r":"888.3071","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A spinal fusion system with 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating is a rigid metallic implant system compromised of single or multiple components intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. The device includes a 12-Methacryloyloxydodecyl Pyridinium Bromide (C21H34BrNO2) coating intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body."},{"c":"QZZ","n":"Limb And Joint Salvage Device With Coating For Bacteria Reduction","k":"2","r":"888.3900","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products."},{"c":"RAA","n":"Laser Products (Pre-Standard)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser product assembled or manufactured before August 1, 1976"},{"c":"RAB","n":"Sunlamp Products (Pre-Standard)","k":"2","r":"878.4635","p":"SU","g":"Y","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.","x":-1},{"c":"RAC","n":"Nondestructive Tests","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Test equipment using ultrasound to analyze an object for defects in commercial or industrial applications"},{"c":"RAD","n":"Gauging","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"Test equipment using ultrasound to determine thickness of material in commercial or industrial applications"},{"c":"RAE","n":"Ranging","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Test equipment used to determine distance to an object using ultrasound in commercial or industrial applications"},{"c":"RAF","n":"Cleaner","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to clean objects in commercial or industrial applications"},{"c":"RAG","n":"Welder","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment used to weld objects in commercial or industrial applications"},{"c":"RAH","n":"Jewelry Cleaner","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to clean jewelry in commercial or household applications"},{"c":"RAI","n":"Motion Detector/Occupancy","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to detect movement in commercial or household applications"},{"c":"RAJ","n":"Security System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to provide security in a commercial or household application"},{"c":"RAK","n":"Pest Repeller","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to repel pests in a commercial or household application"},{"c":"RAL","n":"Massager","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to provide massages in a household application that has no medical claims."},{"c":"RAM","n":"Humidifier","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to disperse water droplets into an area in a household application"},{"c":"RAN","n":"Auto Focus Camera","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Photography equipment using ultrasound to provide range to subject"},{"c":"RAO","n":"Intrusion Alarm/Security","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to provide security and an intrusion alarm in a commercial or household application"},{"c":"RAP","n":"Scientific Use Ultrasound Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound in research or scientific application"},{"c":"RAQ","n":"Audio System/Radio","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment used to produce audible sound in household entertainment applications"},{"c":"RAR","n":"Telephone Ringer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment used to produce a ring tone on a telephone"},{"c":"RAS","n":"Veterinary Diagnostic Ultrasonic Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to diagnose disease in veterinary applications"},{"c":"RAT","n":"Veterinary Therapy Ultrasonic Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using ultrasound to provide physical therapy in veterinary applications"},{"c":"RAU","n":"Night Vision Scope","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An optical device that converts infrared radiation into a visible image through use of an image intensifier tube."},{"c":"RAV","n":"High Voltage Tubes","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Vacuum tubes used in high voltage electronic circuits for purposes other than producing an image."},{"c":"RAW","n":"Cathode Ray Tubes","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A vacuum tube generating a focused beam of electrons that can be deflected by electric fields, magnetic fields or both."},{"c":"RAX","n":"High Voltage Vacuum Switches","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A vacuum tube used for switching high voltages."},{"c":"RAY","n":"Oscilloscope (Exempted)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A device that depicts on a screen periodic changes in an electric quantity, as voltage or current, using a cathode ray tube."},{"c":"RAZ","n":"Television Receiver, Medical Imaging, Color","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A television receiver using a color cathode ray tube to display medical images in colors."},{"c":"RBA","n":"Television Receiver, Medical Imaging, Monochrome","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A television receiver using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color."},{"c":"RBB","n":"Television Receiver, General Purpose, Color","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product designed to receive and, using a color cathode ray tube, to display a television picture in colors from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals."},{"c":"RBC","n":"Television Receiver, General Purpose, Monochrome","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product designed to receive and, using a monochrome cathode ray tube, to display a television picture in black and white with shades of gray or in different shades of one color from broadcast, cable, video disk player, video recorder, computer or closed circuit television signals."},{"c":"RBD","n":"Video Monitor, Medical Imaging, Color","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product using a color cathode ray tube to display medical images in colors from signals from a computer or electronic medical device."},{"c":"RBE","n":"Video Monitor, General Purpose, Color","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product using a color cathode ray tube to display general images in colors from signals from a computer or electronic medical device."},{"c":"RBF","n":"Video Monitor, Medical Imaging, Monochrome","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product using a monochrome cathode ray tube to display medical images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device."},{"c":"RBG","n":"Video Monitor, General Purpose, Monochrome","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product using a monochrome cathode ray tube to display general images in black and white with shades of gray or in different shades of one color from signals from a computer or electronic medical device."},{"c":"RBH","n":"Projector","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Electronic products that use a cathode ray tube or several cathode ray tubes to generate television images which are projected on a screen either from the front or from the rear."},{"c":"RBI","n":"Tv View Finder (Exempted)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product using a cathode ray tube to display the image seen through the lens of a camcorder. To be exempt the cathode ray tube must operate under 5 kilovolts under the test conditions in the standard (phase iii)."},{"c":"RBJ","n":"Cold-Cathode Gas Discharge Tubes","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic device in which electron flow is produced and sustained by ionization of contained gas and ion bombardment of the cathode."},{"c":"RBK","n":"Betatron, Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A betatron used for non-medical applications."},{"c":"RBL","n":"Cyclotron,Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A cyclotron used for non-medical applications."},{"c":"RBM","n":"Microtron, Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A microtron used for non-medical applications."},{"c":"RBN","n":"Synchrotron, Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A synchrotron used for non-medical applications."},{"c":"RBO","n":"Sterilizers, Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A linear accelerator used as a sterilizer for non-medical instruments and applications."},{"c":"RBP","n":"Industrial Accelerator","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An accelerator used for industrial applications."},{"c":"RBQ","n":"Security Accelerator","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A linear accelerator used to non-intrusively search the contents of closed objects such as cargo containers or vehicles for contraband or weapons."},{"c":"RBR","n":"Diagnostic X-Ray Equipment (Noncertified)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a)."},{"c":"RBS","n":"Industrial X-Ray","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"An x-ray system used for industrial purposes to which the cabinet x-ray performance standard does not apply (21 cfr 1020.40)."},{"c":"RBT","n":"Bottle Fill Checker","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"an industrial x-ray system open on the bottom which is used on production lines to determine if containers are filled properly."},{"c":"RBU","n":"X-Ray Thickness Gauge","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An open industrial x-ray system used to measure the thickness of material running through system, usually on a production line."},{"c":"RBV","n":"Security X-Ray System, Open Beam, Small","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An open x-ray system which is used for non-intrusive inspection of containers suspected to contain bombs or other weapons or contraband."},{"c":"RBW","n":"X-Ray Diffraction","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An x-ray system used for x-ray diffraction and used in a laboratory environment."},{"c":"RBX","n":"X-Ray Spectroscopy","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An x-ray system used for x-ray spectroscopy and used in a laboratory environment."},{"c":"RBY","n":"X-Ray Fluorescence","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":5,"d":"An x-ray system for x-ray fluorescence and used in a laboratory environment."},{"c":"RBZ","n":"X-Ray Controls ? Combination","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure."},{"c":"RCA","n":"X-Ray Controls - Fluoroscopic","k":"N","r":"","p":"","g":"N","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating x-ray images and presenting them simultaneously and continuously as visible images."},{"c":"RCB","n":"X-Ray Controls - Radiographic","k":"N","r":"","p":"","g":"N","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure for generating and recordingan x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure."},{"c":"RCC","n":"C-Arm Fluoroscopic X-Ray System","k":"2","r":"892.1650","p":"RA","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":1,"d":"Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient."},{"c":"RCD","n":"X-Ray Image Receptor","k":"N","r":"","p":"","g":"N","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gageous detector, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term \"\"image receptor\"\" shall mean the preselected portion of the device."},{"c":"RCE","n":"Cabinet X-Ray, Industrial","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":24,"d":"A cabinet x-ray system used for quality control, non-destructive testing, or some other industrial purpose."},{"c":"RCF","n":"Cabinet X-Ray Explosive Detection Systems","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A cabinet x-ray system used for detection of explosives in closed containers such as airline baggage. Usually these systems use a non-standard x-ray mode to perform this function such as computed tomography."},{"c":"RCG","n":"Cabinet X-Ray, Security (Includes Baggage X-Ray)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":2,"d":"A cabinet x-ray system used to examine the contents of containers such as airline baggage, brief cases, and purses to detect weapons or other contraband."},{"c":"RCH","n":"Cabinet X-Ray, Vehicle And Cargo","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A large cabinet x-ray system used to examine pallets full of cargo to find weapons or other contraband, or a very large structure that encompasses entire vehicles being examined."},{"c":"RCI","n":"Cephalometric Devices","k":"N","r":"","p":"","g":"N","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A device intended for the radiographic visualization and measurement of the dimensions of the human head."},{"c":"RCJ","n":"Veterinary Diagnostic X-Ray System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A system that is uses x-radiation to visualize anatomical structures in veterinary applications."},{"c":"RCK","n":"Veterinary X-Ray Therapy System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment using x-rays to provide therapy in veterinary applications."},{"c":"RCL","n":"Ion Beam Implanter","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic system that implants ions for fabrication of semiconductor materials."},{"c":"RCM","n":"Microscope (Electron Beam), Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"a particle beam system used to view objects or details too small to view with an optical microscope."},{"c":"RCN","n":"Personnel Security Backscatter X-Ray System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A system intended to find contraband, explosives, and weapons concealed under the clothing of a person through the use of backscattered x-rays."},{"c":"RCO","n":"Personnel Security Transmission X-Ray System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A system intended to find contraband, explosives, and weapons concealed under the clothing of a person or inside a person through the use of transmitted x-rays."},{"c":"RCP","n":"Vehicle And Cargo X-Ray System, Mobile","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A mobile system, usually mounted in a truck or similar conveyance which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers."},{"c":"RCQ","n":"Vehicle And Cargo X-Ray System, Stationary","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A large system often in its own architectural structure, that does not encompass entire vehicles or cargo containers, which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers which pass through the system."},{"c":"RCR","n":"Microwave Oven, Consumer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A machine that utilizes microwave radiation for food preparation, designed for home use."},{"c":"RCS","n":"Microwave Oven, Commercial","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A machine that utilizes microwave radiation for food preparation, designed for commercial establishments"},{"c":"RCT","n":"Tunnel/Conveyor","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for food preparation using a conveyorized or tunnel microwave waveguide."},{"c":"RCU","n":"Vending Machine","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for dispensing heated foods in public areas."},{"c":"RCV","n":"Food Processing","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for food preparation, primarly used in commercial food industry"},{"c":"RCW","n":"Materials Processing","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for industry drying/heating of non-food products (non-dielectric heater rf sealers)"},{"c":"RCX","n":"Clothes Dryer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation to warm and dry clothing."},{"c":"RCY","n":"Medical Waste/Sterilizer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for treating or sterilizing medical waste."},{"c":"RCZ","n":"Materials Processing, Laboratories","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for materials processing, custom designed or modified off-shelf for laboratories."},{"c":"RDA","n":"Dielectric Heaters, Induction Heaters, Rf Sealers","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes industrial radiofrequency (rf) induction heating with rf fields in frequency range from 2-500 mhz for industrial heating."},{"c":"RDB","n":"Electric Blanket","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave or elf radiation in an electric blanket."},{"c":"RDC","n":"Shavers","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave or elf radiation for shaving hair."},{"c":"RDD","n":"Hair Dryer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave or elf radiation for drying hair."},{"c":"RDE","n":"Sewing Machine","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A machine that utilizes microwave or elf radiation for fabric treatment, incorporated in a sewing machine."},{"c":"RDF","n":"Motor","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave or elf radiation in a motor."},{"c":"RDG","n":"Veterinary, Microwave Medical Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for veterinary treatments."},{"c":"RDH","n":"Air Traffic Control","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the air traffic control environment."},{"c":"RDI","n":"Police Radar","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation associated with identification, safety, security, or surveillance in the police traffic control environment."},{"c":"RDJ","n":"Rf Identification","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for rf id tags for security, tracking, inventory control, surveillance, etc."},{"c":"RDK","n":"Electronic Article Surveillance (Eas)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation used by retailers to prevent theft of merchandise or products"},{"c":"RDL","n":"Stun Gun","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation in a stun gun used by law enforcement and military."},{"c":"RDM","n":"Anti-Theft Detector (Non-Eas)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation (not eas or rfid) for security, tracking, inventory control, surveillance, etc."},{"c":"RDN","n":"Walkie-Talkie","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for communication as in walkie talkies."},{"c":"RDO","n":"Microwave Lan","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for communication and data transmission in a local area network."},{"c":"RDP","n":"Wireless (Cordless) Telephone","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for communication in a wireless, cordless telephone."},{"c":"RDQ","n":"Cb Amateur Radio","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for communication in a cb amateur radio."},{"c":"RDS","n":"Weather Doppler","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for data and measurement transmission in a weather doppler system."},{"c":"RDT","n":"Rf-Excited Lighting","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for rf-excited lighting."},{"c":"RDU","n":"Pest Controller","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for pest control."},{"c":"RDV","n":"Automotive Accessory, Automobile Or Transport Vehicle","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser product or product containing a laser that is an automotive or other transport vehicle accessory."},{"c":"RDW","n":"General Purpose Laser Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":5,"d":"Product, laser, general, emit beam; A laser or product containing a laser that is intended for general purpose use."},{"c":"RDX","n":"Mercury Vapor Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"High intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and manufactured after march 7, 1980."},{"c":"RDY","n":"Metal Halide Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"High-intensity mercury vapor discharge lamp means any lamp including any mercury vapor or metal halide lamp, with the exception of tungsten filament self-ballasted mercury vapor lamp, incorporating a high pressure arc discharge tube that has a fill consisting of mercury and that is contained within an outer envelope."},{"c":"RDZ","n":"Low-Power Laser Light Show Projector","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"Product, laser, demo, projector, laser light show/display, class iiia/3r and lower; Laser projection system that incorporates a laser having a maximum radiation output of less than 5mw."},{"c":"REA","n":"High-Power Laser Light Show Projector","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":12,"d":"Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw."},{"c":"REB","n":"High-Power Laser Light Show","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, demo, laser light show/display, class iiib/iv/3b/4; Laser light show or demonstration using laser projection equipment having an output that exceeds 5mw"},{"c":"REC","n":"Laser Video Projector","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A raster-scanned digital image projector that uses a scanned laser beam in conjunction with or incorporated in a video display system or projector."},{"c":"RED","n":"Laser Advertising Display System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, demo, system, display, advertising"},{"c":"REE","n":"Laser Visual Display - Display Retinal Image, Non-Medical","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, display, system, images, direct to retina"},{"c":"REF","n":"Suntan Bed","k":"2","r":"878.4635","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning."},{"c":"REG","n":"Suntan Lamp","k":"2","r":"878.4635","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":1,"d":"A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture."},{"c":"REH","n":"Tabletop Sunlamp System","k":"2","r":"878.4635","p":"SU","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers."},{"c":"REI","n":"Laser Science Education Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, demo, education, illustrate science principles"},{"c":"REJ","n":"Laser Children'S Toy/Novelty Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, children's toy/novelty"},{"c":"REK","n":"Research Laser","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":5,"d":"Product, laser, research/laboratory; A laser under development in and of itself. A laser used for conducting research during development of new data or to improve a process would not be considered a research laser although it is being used in research."},{"c":"REL","n":"Guide-Star Laser System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, adaptive-optics telescope focusing accessory, generate artificial star; A laser used for focusing adaptive-optics telescopes."},{"c":"REM","n":"Spectroscopy Instrument","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":5,"d":"Product, laser, instrument, spectroscopy; An instrument incorporating a laser for spectroscopic testing or examination"},{"c":"REN","n":"Particle-Size Measuring Instrument","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining the size or number of particles of particles a test sample."},{"c":"REO","n":"Analytical Measuring And Detection Laser Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"Product, laser, instrument, analyze/detect chemical species"},{"c":"REP","n":"Surveying Laser Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":4,"d":"Product, laser, surveying, instrument, determine position by measurement of angles"},{"c":"REQ","n":"Laser Rangefinders, Time-Of-Flight Speed Measurement Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"Product, laser, measures speed by time-of-flight. Includes laser range finders."},{"c":"RER","n":"Alignment Laser Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":4,"d":"Product, laser, alignment, aid positioning or adjusting parts in relation to each other"},{"c":"RES","n":"Laser Pointer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, pointer, indicate point of interest; A laser product intended specifically to define a spot or surface for drawing attention to a viewer."},{"c":"RET","n":"Laser Target Designator","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"Product, laser, target designator; An optical devices, using a beam of laser radiation that permits the alignment of a firearm-type product such as a gun, cannon, or rocket system with its target."},{"c":"REU","n":"Laser Aiming Product, Visible","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":2,"d":"Product, laser, aiming, visible, attached to weapon; An optical devices, using a visible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target"},{"c":"REV","n":"Laser Aiming Product, Non-Visible","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, aiming, infrared, attached to weapon, viewed with night-vision equipment; An optical devices, using an invisible beam of laser light that permits the alignment of a gun, cannon or rocket system with its target."},{"c":"REW","n":"Ir Laser Illuminator With Alignment Aid/Night Vision System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, infrared, illuminator with alignment aid, viewed through night-vision equipment"},{"c":"REX","n":"Ir Laser Illuminator Only/Night Vision System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"Product, laser, infrared, illuminator only, viewed through night-vision equipment"},{"c":"REY","n":"Collision-Avoidance Laser System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, infrared, collision-avoidance system"},{"c":"REZ","n":"Laser Traffic Signal","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, traffic signal/control"},{"c":"RFA","n":"Laser Automotive Lighting & Signals","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, automotive, lighting/signals"},{"c":"RFB","n":"Ir Laser Intrusion Detection/Security System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, infrared, intrusion detecting, security system"},{"c":"RFC","n":"Laser Distance, Detection, Ranging (Lidar)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"Product, laser, for distance, detection or ranging measurement."},{"c":"RFD","n":"Laser Weapon (Military Or Police)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, weapon (military/police)"},{"c":"RFE","n":"Laser Cutter","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"A high power laser intended to cut or drill a variety of materials in an industrial or commercial environment."},{"c":"RFF","n":"Laser Welder","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A high power laser intended to weld (join) materials in an industrial or commercial environment."},{"c":"RFG","n":"Microelectronic Mask Or Chip Processing, Checking, And/Or Repair","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser intended to process, inspect, and/or repair microelectronic components in an industrial or commercial environment."},{"c":"RFI","n":"Print Industry Plate Maker","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser intended to etch, engrave or otherwise create printer's plates used in an industrial or commercial environment."},{"c":"RFJ","n":"Process Control","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used for inspection, counting, or other application intended to monitor a part of the manufacturing process in an industrial or commercial environment. Often incorporated in an automated process system."},{"c":"RFK","n":"Laser Vision","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A laser used for positioning, focusing, inspection, counting, or other application in an industrial or commercial environment. Often incorporated in an automated assembly line system."},{"c":"RFL","n":"Laser Micrometer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used in high precision dimensional measurements in materials processing."},{"c":"RFM","n":"Laser-Based Material Positioning System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used in precision positioning of materials in manufacturing in an industrial or commercial environment."},{"c":"RFN","n":"Fiber Optic Communication And Data Transfer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"A laser used in fiber optic communications to transmit data and information."},{"c":"RFO","n":"Ir Free-Space Data Transmit/Control Laser","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used in free space (open air) communications to transmit data and information."},{"c":"RFP","n":"Remote Controller","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used to transmit signals and/or information in order to operate equipment or machinery remotely."},{"c":"RFQ","n":"Interferometric Position Measuring Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used as an interferometer for high precision positioning and/or measurements."},{"c":"RFR","n":"Product Incorporating Certified Class 1 Laser Data Measurement, Transmit, Control Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A data measurement, data transmission, or remote control product that incorporates a certified class 1 laser."},{"c":"RFS","n":"Reprographics","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A reprographics machine that incorporates a laser utilized to expose internal sensitive components or materials for photocopying text and graphics."},{"c":"RFT","n":"Laser Printer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A printing machine that incorporates a laser utilized in printing images on paper."},{"c":"RFU","n":"Laser Fax Machine","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A printing machine that incorporates a laser utilized in printing fascimilies of images on paper."},{"c":"RFV","n":"Cd, Cd-Rom Player","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A cd or cd-rom player that utilizes a laser to read data on the compact disc."},{"c":"RFW","n":"Dvd, Dvd-Rom, Bluray, Hd Player","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A dvd, dvd-rom, bluray, or high definition (hd) player that utilizes a laser to read data on the digitally recorded video disc."},{"c":"RFX","n":"Cd-R, Cd-Rw Recorder","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A cd-r or cd-rw recorder machine that utilizes a laser to read and/or write data on the compact disc."},{"c":"RFY","n":"Dvd, Bluray, Or Hd Recorder","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A dvd, bluray, or hd recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: Dvd-r, dvd+r, dvd-ram, dvd-rw, or dvd+rw, or bluray or hd recorders or read/writers."},{"c":"RFZ","n":"Upc Scanner Reader (Bar Code Reader)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":2,"d":"A laser used to scan across a bar code to identify the product. Bar code readers can be hand-held accessories, under-counter components incorporated in store check-out systems, or laser scanner systems incorporated in assembly lines used for identification and inventory purposes in manufacturing facilities, warehouses and storage facilities, or other consumer, industrial, health care, or commercial locations."},{"c":"RGA","n":"Product Incorporating Certified Class 1 Data Utility/Peripheral Laser Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":2,"d":"A utility/peripheral laser product that incorporates a certified class 1 laser."},{"c":"RGB","n":"Veterinary Laser","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A laser used for treatment of animals other than human"},{"c":"RGC","n":"X-Ray Field Indicator Light (Laser)","k":"1","r":"892.5780","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A laser incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement."},{"c":"RGD","n":"Counterfeit Detection","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used for detection of counterfeit money."},{"c":"RGE","n":"Scientific Crystallography","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used in crystallography for identification."},{"c":"RGF","n":"Forensics","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used in forensics for fingerprint detection."},{"c":"RGG","n":"Forensics Laser","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength laser used in forensics for fingerprint detection."},{"c":"RGH","n":"Toilet Seat Sanitizer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used for sanitizing toilet seats."},{"c":"RGI","n":"Hand Washing Sanitizer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used for sanitizing hands after washing."},{"c":"RGJ","n":"Countertop Sanitizer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used for sanitizing a countertop."},{"c":"RGK","n":"Towel Cleaner","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used for sanitizing towels in a towel washing process."},{"c":"RGM","n":"Photochemical Curing And Adhesive","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light \"\"cures\"\" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc."},{"c":"RGN","n":"Photochemical Curing And Adhesive Laser","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength laser light source used to illuminate a material of a certain composition such that the light \"\"cures\"\" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc."},{"c":"RGO","n":"Uv Curing","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used to illuminate a material of a certain composition such that the light \"\"cures\"\" or causes a chemical reaction to change the material in a desired fashion. Typical materials are adhesives, plastics, potting compounds, etc."},{"c":"RGP","n":"Black Light","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used to illuminate a fluorescent material to produce fluorescence."},{"c":"RGQ","n":"Cosmetology Uv Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used to irradiate skin, nails, or hair for cosmetic purposes (excluding tanning)."},{"c":"RGS","n":"Water Purifier","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used to sanitize water."},{"c":"RGT","n":"Spectroscopy, Ultraviolet Fluorescence","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An ultraviolet wavelength noncoherent light source used to stimulate ultraviolet fluorescence."},{"c":"RGU","n":"X-Ray Field Indicator Light Field (Non-Laser)","k":"N","r":"","p":"","g":"N","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A noncoherent light source incorporated in a diagnostic x-ray system that is irradiated onto the film screen area indicating the x-radiation area. The beam is usually scanned to show a rectangular region for patient placement."},{"c":"RGV","n":"Veterinary Optical Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A noncoherent light source used in veterinary medicine."},{"c":"RGW","n":"Uv/Ir Research","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A noncoherent ultraviolet or infrared light source used in research."},{"c":"RGX","n":"Fluorescent Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A general purpose fluorescent lamp used for illumination."},{"c":"RGY","n":"Ir Intrusion Detector","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A noncoherent infrared light source used to detect motion to protect against intrusion."},{"c":"RGZ","n":"Ir Security","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A noncoherent infrared light source used for security."},{"c":"RHA","n":"Ir Data Transmit/Control","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A noncoherent infrared source used for data transmission or remote control of another product or machine."},{"c":"RHB","n":"Tungsten Halogen Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A tungsten halogen lamp."},{"c":"RHC","n":"High Pressure Mercury, Metal Halide, And Mercury Xenon Lamp (Not For General Purpose Illumination)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A high pressure mercury vapor, metal halide, or mercury xenon lamp used for a specific purpose and not intended for general purpose illumination. Specific examples are lamps used in scientific and industrial equipment, projection televisions and computer projectors, searchlights, etc."},{"c":"RHD","n":"Ir Remote Controller","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A noncoherent infrared light source used to transmit signals and/or information in order to operate equipment or machinery remotely."},{"c":"RHF","n":"Digital Display Monitor","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A monitor or projector that uses a high intensity light source to illuminate pixels to produce images driven from a digital image source."},{"c":"RHG","n":"Light, Spectrum, Broad (Non-Medical)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A broad spectrum output noncoherent light source intended for general purpose."},{"c":"RHH","n":"Led Lamps Emitting Visible Light Intended To Be Used For Illumination Purposes","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"LED lamps emitting predominantly visible and/or white light intended to be used for illumination purposes. These include illumination products, flashlights, finished bulbs or lamps."},{"c":"RHI","n":"Mercury Vapor Lamp, Not Self-Extinguishing, R-Type","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"High intensity mercury vapor discharge lamp, not self-extinguishing, r lamp"},{"c":"RHJ","n":"Television, Less Than 25kv And Less Than 0.1 Mr/Hr","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Television product, less than 25 kilovolt and less than 0.1 milliroentgen per hour"},{"c":"RHK","n":"Laser Marker Or Engraver, Industrial Or Commercial","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":3,"d":"A laser intended to mark or engrave an object with text, logos, etc. Using either a mask or a scanned laser beam."},{"c":"RHL","n":"Laser Therapy Product","k":"N","r":"","p":"","g":"N","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Non-surgical laser used on parts of the human body for therapeutic uses, such as pain management."},{"c":"RHM","n":"Image Digitizer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Product, laser, image digitizer; Converts analog image into digital image format."},{"c":"RHN","n":"Fiber Optic Instrument For Testing Optical Fibers","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser used in an instrument for testing and characterizing optical fibers."},{"c":"RHO","n":"Sound Amplification Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Intended to amplify environmental sound for non-hearing impaired consumers"},{"c":"RHP","n":"Uv Lamp, Germicidal","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":8,"d":"An ultraviolet wavelength noncoherent light source intended for use in general purpose, germicidal systems."},{"c":"RHQ","n":"Hologram Displaying Or Creating Laser Product.","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Laser product or product containing a laser that is for the creation or display of holograms for entertainment, artistic, or educational purposes."},{"c":"RHR","n":"Laser Holographic System For Experiments, Research, Or Prototype Development","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser holographic system intended to be used for experimental or research purposes; May be prototypes for later manufacturing"},{"c":"RHS","n":"Laser Holographic System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser holographic system intended for measurement or process control in manufacturing, inspection, diagnosis or similar engineering activities"},{"c":"RHT","n":"Laser Mouse, Trackball, Or Similar","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A mouse or trackball related to a computer or similar electronic tool, used to control the curser on the screen interface."},{"c":"RHU","n":"Led For Signaling/Tracking/Triggering","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Products that incorporate light emitting diodes (LEDs) to be used in relation to a computer or electronic tool, to signal/trigger a sensor, to track movement, or control the product."},{"c":"RHV","n":"Metal Deposition Laser Product","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A Laser driven metal deposition system."},{"c":"RHW","n":"Uv Lamp For Home Or Business Uses","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Uv noncoherent lamp product intended for consumer or commercial use; Including printing, reprographics, and other such processes"},{"c":"RHX","n":"Sodium Vapor Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A sodium vapor lamp is a gas discharge lamp that uses sodium in an excited state to product light. There are two varieties of such lamps: Low pressure and high pressure. It is for general purpose illumination."},{"c":"RHY","n":"Laser Sensing System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Laser wavefront sensing and/or topographic measurement sensor system."},{"c":"RHZ","n":"3d Laser Scanning System","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A 3d laser scanning system to be used in an accurate free form process to capture physical objects and produce a complete digital representation of the object for applications such as reverse engineering, prototyping, design, modeling, or others."},{"c":"RIA","n":"High Intensity Lamp","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"High intensity mercury vapor or metal halide lamp, intended for general purpose illumination, but of such a design that breakage of an outer envelope will not result in increased uv emissions."},{"c":"RIB","n":"Microscopy Laser Instrument Or Accessory Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":2,"d":"A laser product for microscopic studies of samples or a microscope laser accessory to assist in such microscopic studies."},{"c":"RIC","n":"Ultrasonic Cutter","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Equipment used to cut objects in commercial or industrial applications."},{"c":"RID","n":"Liquid Crystal Display (Lcd)","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A liquid crystal display (LCD) is a flat panel display that uses the light modulating properties of liquid crystal."},{"c":"RIE","n":"Visible Laser Illuminator","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Laser product, visible wavelength, illuminator."},{"c":"RIF","n":"Smart Meter","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electrical meter that records consumption of a consumable product delivered by a utility company and communicates wirelessly back to the utility company for monitoring and billing purposes."},{"c":"RIG","n":"Laser Illuminated Projector","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A full-frame digital image projector which incorporates lasers and possibly other light sources to illuminate image processing components."},{"c":"RIH","n":"Metal Halide Lamp, Other","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Any metal halide lamp, including sodium vapor, that does not incorporate a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope."},{"c":"RII","n":"Scientific Optical Instrument, Noncoherent","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Any scientific or research instrument that incorporates or uses any noncoherent light source."},{"c":"RIJ","n":"Automotive Radar","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A machine that utilizes microwave radiation for object detection and collision avoidance."},{"c":"RIK","n":"Television Or Monitor, Non-Crt, Non-Medical, Video Display","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"An electronic product designed to receive and display television or video signals from broadcast, cable, video player or recorder, computer, or other source. This may be a receiver or monitor or similar. This does not use a cathode ray tube (CRT) to display the image. This would include LED, OLED, LCD, Plasma technology televisions/monitors."},{"c":"RIL","n":"Laser Ignition Tool","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"product which is designed to use laser emission to ignite a material."},{"c":"RIM","n":"Laser Marker, Cutter, Or Engraver, Tabletop, Consumer","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":1,"d":"A laser intended for consumer, non-industrial, applications to mark, cut, or engrave objects with text, logos, etc. using either a mask or a scanned laser beam in a portable/tabletop/desktop size, often marketed as do it yourself (DIY) tools."},{"c":"RIN","n":"Laser Illuminated Lighting Instrument","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"A laser illuminated spotlight used for entertainment lighting effects."},{"c":"RIO","n":"Led Toys And Entertainment Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Products that incorporate light emitting diodes (LEDs) to be used in toys or entertaiment products to control, illuminate, or interact with the user. These products include LED \"lasertag\" toys, and blacklights for home use."},{"c":"RIP","n":"Led Diodes Sold As Components To Be Installed In Finished Electronic Products","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"LEDs sold as components to be installed in finished electronic products, such as bare LED diodes and LED diode arrays without control or power modules or standard lamp fitting included. Not including finished bulbs or lamps."},{"c":"RIQ","n":"Low Emission Leds As Indicators Or Decorations","k":"N","r":"","p":"","g":"Y","l":"","i":"","t":"","m":"Ineligible","s":"","u":"","a":0,"b":0,"e":0,"d":"Finished LED products intended to act as an indicator or for decorative purposes, such as Christmas tree lights or display backlighting. LED product only intending to emit visible radiation at low intensities."},{"c":"SAB","n":"Table Mounted Miniaturized Electromechanical Surgical System","k":"2","r":"878.4962","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":1,"d":"A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms"},{"c":"SAC","n":"Adamts13 Activity Test System","k":"2","r":"864.7297","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings."},{"c":"SAD","n":"Japanese Encephalitis Virus Immunological/Serology Test","k":"N","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"3","a":0,"b":0,"e":0,"d":"Product code for export only"},{"c":"SAF","n":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional."},{"c":"SAH","n":"Magnetic Compression Anastomosis System","k":"2","r":"878.4816","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":9,"b":0,"e":0,"d":"A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally. This classification does not include devices intended for weight loss or metabolic disease treatment"},{"c":"SAI","n":"Ankle Fusion Cage","k":"2","r":"888.3020","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use."},{"c":"SAK","n":"Software Device To Aid In The Prediction Or Diagnosis Of Sepsis","k":"2","r":"880.6316","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis."},{"c":"SAL","n":"Device, Automated Cell Locating, Bone Marrow","k":"2","r":"864.5261","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type."},{"c":"SAM","n":"Battery-Powered Instruments Charged Through Sterile Barriers","k":"1","r":"878.4820","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer."},{"c":"SAN","n":"Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples","k":"2","r":"866.1650","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":8,"b":0,"e":0,"d":"Automated system that performs antimicrobial susceptibility testing using positive blood culture samples"},{"c":"SAO","n":"Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density","k":"2","r":"892.1171","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes."},{"c":"SAP","n":"Computerized Behavioral Therapy Device For Depressive Disorders.","k":"2","r":"882.5801","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The device is intended to provide computerized behavioral therapy to treat depressive disorders."},{"c":"SAQ","n":"Electromechanical System For Open Microsurgery","k":"2","r":"878.4963","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm."},{"c":"SAR","n":"Adjunctive Hemodynamic Indicator With Decision Point For Military Use","k":"2","r":"870.2220","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military."},{"c":"SAT","n":"Pulmonary Hypertension Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up."},{"c":"SAW","n":"Fluorescence Imaging For Breast Cancer Detection","k":"3","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"The combination product consists of an optical imaging agent for injection, and a fluorescence imaging device. The product is intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The imaging device is used with the imaging drug for fluorescence imaging of the lumpectomy cavity."},{"c":"SAX","n":"Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device","k":"2","r":"886.1600","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments."},{"c":"SAZ","n":"Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"As an aid in the management of chronic intractable phantom limb post amputation pain and pain in the residual limb post amputation."},{"c":"SBA","n":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","k":"2","r":"862.1357","p":"CH","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site."},{"c":"SBB","n":"System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":1,"d":"The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy."},{"c":"SBC","n":"Dental Image Analyzer","k":"2","r":"872.1770","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress."},{"c":"SBE","n":"Digital Physical/Chemical Sterilization Process Sensor","k":"2","r":"880.2801","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result."},{"c":"SBF","n":"Orthopedic Augmented Reality","k":"2","r":"882.4560","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":43,"b":0,"e":2,"d":"An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view."},{"c":"SBG","n":"In Situ Polymerizing Peripheral Nerve Cap","k":"2","r":"882.5260","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma."},{"c":"SBH","n":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter","k":"2","r":"862.1355","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices."},{"c":"SBI","n":"Manual Refractor, 3d Display","k":"1","r":"886.1770","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye."},{"c":"SBK","n":"Artificial Chordae Tendineae Surgical Replacement System","k":"2","r":"870.3490","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access."},{"c":"SBL","n":"Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Melanoma-associated antigen A4 (MAGE-A4) antibody is a qualitative immunohistochemical antibody, intended for use in the detection of MAGE-A4 protein expression in human clinical tissue specimens. The MAGE A4 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"SBN","n":"Digital Therapy Device For Convergence Insufficiency","k":"1","r":"886.1290","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency"},{"c":"SBO","n":"Bed-Patient Activity Monitoring System","k":"1","r":"880.2400","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or other signal when patient activity deviates from assigned pressure prevention parameters."},{"c":"SBP","n":"Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test","k":"2","r":"866.3171","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A simple point-of-care nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) test is an in vitro diagnostic device that is intended for prescription use for the detection of HCV RNA in clinical specimens as an aid in the diagnosis of HCV infection or as an aid in the management of HCV-infected patients, including individuals without antibodies to HCV. This device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The test is not intended for use as a donor screening test for the presence of HCV RNA in blood, blood products, or tissue donors."},{"c":"SBQ","n":"Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up."},{"c":"SBS","n":"Laryngeal Injection Set With Led Light","k":"1","r":"874.4420","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A light guided laryngeal injection set is an ear, nose, and throat manual surgical instrument and is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar"},{"c":"SBT","n":"Device To Detect Microbial Colonization Directly From Clinical Specimens.","k":"2","r":"866.3967","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings."},{"c":"SBX","n":"Software For Endoscopy Procedure Metrics","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Software that analyzes gastrointestinal (i.e., esophagus, stomach, small bowel, and colon) endoscopy procedure¿data to assess or document the procedure metrics such as completeness of the endoscopic procedure conducted by an appropriately trained healthcare provider; and to provide feedback to the healthcare provider on procedural metrics that are part of the standard of care. The health care provider is responsible for verifying and interpreting the procedural metric data with regard to patient management. The software function does not aid the healthcare provider in the detection of lesions nor does the software function aid the healthcare provider to identify characteristics of the patient, anatomy, or lesion that may be used for diagnosis of a disease or condition.¿The software does not output treatment recommendations."},{"c":"SBY","n":"High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids","k":"2","r":"866.6085","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product."},{"c":"SBZ","n":"Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users","k":"2","r":"866.3986","p":"MI","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Test for detection of antibodies associated with syphilis performed by lay users is an in vitro diagnostic device used for detection of antibodies in clinical specimens for use in home settings, or similar environments. The device is intended to aid in diagnosis of syphilis and intended for prescription use or over-the-counter use."},{"c":"SCA","n":"Multi-Analyte Respiratory Virus Antigen Detection Test","k":"2","r":"866.3987","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":13,"b":0,"e":0,"d":"A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport."},{"c":"SCB","n":"Deflation Needle For Removal Of Intragastric Balloon","k":"2","r":"876.1550","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Deflation needle is a prescription use device intended to puncture and drain fluid from an intragastric balloon so that the empty balloon may be removed endoscopically."},{"c":"SCE","n":"Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286)."},{"c":"SCF","n":"Ldt, Unmet Need Within An Integrated Healthcare System","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286)."},{"c":"SCG","n":"Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"When a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting CLIA’s regulatory requirements to perform high complexity testing modifies another manufacturer’s 510(k) cleared or De Novo authorized test, and in compliance as described in section V.C.3 of the preamble to the LDT Final Rule, in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification as described in sections V.C.4 and V.C.5 of the preamble to the LDT Final Rule (89 FR 37286)."},{"c":"SCH","n":"Ldt, Approved By Nys Clep","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Laboratory developed tests (LDTs) that are approved by the New York State Department of Health Clinical Laboratory Evaluation Program (NYS CLEP) described in section V.B.2 of the preamble to the LDT Final Rule (89 FR 37286)."},{"c":"SCI","n":"Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286)."},{"c":"SCJ","n":"Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B of the preamble to the LDT Final Rule (89 FR 37286)."},{"c":"SCK","n":"Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd","k":"N","r":"","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"Non-molecular antisera laboratory developed tests (LDTs) for rare red blood cell (RBC) antigens when manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative in vitro diagnostic product (IVD) available to meet the patient's need for a compatible blood transfusion within the scope described in Section V.B.3 of the preamble to the Final LDT Rule (89 FR 37286)."},{"c":"SCL","n":"Allergen And Vaccine Delivery Needles","k":"2","r":"880.5570","p":"HO","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":25,"b":0,"e":0,"d":"An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests."},{"c":"SCN","n":"Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief","k":"2","r":"882.5870","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A temporarily implanted peripheral nerve stimulation system for sustained pain relief is a prescription device that uses an external electrical stimulator(s) and percutaneous electrode(s) to stimulate a peripheral nerve(s) to provide sustained pain relief after the end of treatment."},{"c":"SCP","n":"Computerized Behavioral Therapy Device For Anxiety Disorders","k":"2","r":"882.5801","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Computerized behavioral therapy device for psychiatric disorders"},{"c":"SCR","n":"Air-Conduction Hearing Aid Software","k":"2","r":"874.3335","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325."},{"c":"SCS","n":"Ultraviolet Radiation Disinfection Chamber Device","k":"2","r":"880.6511","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation."},{"c":"SCT","n":"Foley Catheters And Accessories With Additional Safety Features","k":"2","r":"876.5130","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections."},{"c":"SCU","n":"Dna And Rna Oncology Controls","k":"2","r":"866.5910","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls."},{"c":"SCV","n":"Modular Electromechanical Surgical System","k":"2","r":"878.4964","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":1,"d":"A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures."},{"c":"SCW","n":"Digital Prismatic Correction","k":"1","r":"886.1655","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":2,"b":0,"e":0,"d":"The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction."},{"c":"SCX","n":"Immunoassay For Host Biomarkers Of Sepsis","k":"2","r":"866.3215","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens."},{"c":"SCY","n":"Sacroiliac Joint Guidewire Placement Device","k":"2","r":"888.3040","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint."},{"c":"SCZ","n":"Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures","k":"2","r":"870.1254","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures."},{"c":"SDA","n":"Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer","k":"3","r":"","p":"AN","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen."},{"c":"SDB","n":"Tracheal Prosthesis With Cover Material Derived From Human Sources","k":"2","r":"868.3721","p":"AN","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors."},{"c":"SDC","n":"Qualitative Cleaning Process Protein Indicator","k":"2","r":"880.6930","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":2,"d":"A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract."},{"c":"SDD","n":"Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field","k":"2","r":"878.4965","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":5,"b":0,"e":0,"d":"An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use."},{"c":"SDE","n":"Light Based Device For Dry Age-Related Macular Degeneration","k":"2","r":"886.5520","p":"OP","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":1,"d":"A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration."},{"c":"SDG","n":"Brain Intraparenchymal Infusion Cannula","k":"2","r":"882.4110","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy."},{"c":"SDJ","n":"Adjunctive Cardiac Amyloidosis Status Indicator","k":"2","r":"870.2200","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."},{"c":"SDK","n":"Transdermal Test For Assessment Of Glomerular Filtration Rate","k":"3","r":"","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A test used to assess a patient’s glomerular filtration rate (GFR) by injecting a fluorescent tracer molecule into the blood stream and measuring the amount of fluorescence through the skin with a transdermal sensor."},{"c":"SDL","n":"Transvenous Temporary Phrenic Nerve Stimulator","k":"3","r":"","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older."},{"c":"SDM","n":"Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps","k":"U","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":0,"d":"For the qualitative detection of infectious disease agents in human cadaveric (non-heart-beating) specimens"},{"c":"SDN","n":"Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps","k":"U","r":"","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"3","u":"1","a":0,"b":0,"e":0,"d":"For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens"},{"c":"SDO","n":"Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation","k":"2","r":"890.5851","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit."},{"c":"SDP","n":"Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit","k":"2","r":"864.1861","p":"MG","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A kappa and lambda immunoglobulin light chain in situ hybridization (ISH) mRNA probe is intended as an aid in the identification of hematolymphoid neoplasms using in situ hybridization. A Kappa and Lambda ISH mRNA probe cocktail is indicated for use when a hematolymphoid biopsy (e.g., bone marrow, lymphoid tissue) yields inconclusive results. The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms"},{"c":"SDQ","n":"Alfapump System","k":"3","r":"","p":"GU","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination."},{"c":"SDS","n":"Compression-Based Airway Clearance Device","k":"2","r":"868.5665","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax."},{"c":"SDT","n":"Intra-Pulmonary Percussive Vibration (Ipv) Devices","k":"2","r":"868.5665","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":3,"b":0,"e":0,"d":"It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways."},{"c":"SDV","n":"Clinical Electronic Thermometer","k":"2","r":"880.2910","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":0,"b":0,"e":0,"d":"A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf"},{"c":"SDW","n":"Stationary Infrared Thermometer","k":"2","r":"880.2910","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"A stationary infrared thermometer is a free-standing or mounted clinical electronic thermometer indicated to measure a person’s body temperature. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf."},{"c":"SDX","n":"Neuromuscular Stimulator And Exercise Evaluation System","k":"2","r":"882.1871","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions."},{"c":"SDY","n":"Loss Of Pulse Notification Software","k":"2","r":"870.2790","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis."},{"c":"SDZ","n":"Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":2,"e":0,"d":"Endovascular Repair of Ascending Aorta and Aortic Arch Lesions"},{"c":"SEA","n":"Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users","k":"2","r":"866.3386","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is an in vitro diagnostic device for the detection and/or differentiation of nucleic acids from non-viral microorganism(s) causing sexually transmitted infections in clinical specimens for use in home settings, or similar environments. The test is intended for prescription or over-the-counter use."},{"c":"SEC","n":"Wearable Fall Injury Prevention Device","k":"2","r":"890.3780","p":"PM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A wearable fall injury prevention device is intended to detect falls and prevent major fall injuries. Once a fall is detected, the device deploys a protective mechanism to reduce the risk of injury."},{"c":"SEE","n":"Computerized Behavioral Therapy Device For Migraine","k":"2","r":"882.5806","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache."},{"c":"SEF","n":"Central Venous Catheter With Manual Insertion System","k":"2","r":"880.5200","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel."},{"c":"SEG","n":"Leadless Cardiac Resynchronization Therapy (Crt)","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant"},{"c":"SEI","n":"Qualitative And Quantitative Hepatitis B Virus Antibody Assays","k":"2","r":"866.3173","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":30,"e":0,"d":"In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown."},{"c":"SEJ","n":"Wound Dressings Containing Topical Analgesics","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":6,"b":0,"e":0,"d":"A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain."},{"c":"SEK","n":"Wound Dressings With Hydrocortisone","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":2,"b":0,"e":0,"d":"A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound"},{"c":"SEL","n":"Securement Wound Dressing For Reduction Of Infection","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":3,"b":0,"e":0,"d":"These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI)."},{"c":"SEM","n":"Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring","k":"2","r":"882.1360","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patient’s brain. The device is not intended to be implanted in brain tissue."},{"c":"SEN","n":"Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety","k":"2","r":"882.5050","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A biofeedback device for adjunctive treatment of patient-reported symptoms associated with stress and anxiety is intended to provide feedback to users with patient-reported symptoms associated with stress and anxiety on a physiological measurement as a relaxation treatment for the reduction of stress and anxiety."},{"c":"SEP","n":"Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay","k":"2","r":"866.2920","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated."},{"c":"SEQ","n":"Covered Stent Vascular Connector, Hemodialysis Access Circuit","k":"3","r":"","p":"CV","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is intended for suture-less attachment between an arteriovenous (AV) graft to a native vessel or between two native vessels (i.e., lack of suture placement on one or both ends) for the creation of a hemodialysis access site."},{"c":"SER","n":"Immunohistochemistry Assay, Antibody, Met","k":"3","r":"864.1860","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs."},{"c":"SES","n":"Non-Factor Replacement Product Test System","k":"2","r":"864.7298","p":"HE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling."},{"c":"SET","n":"Immunoassay Blood Test For Amyloid Pathology Assessment","k":"2","r":"866.5840","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":7,"d":"An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimer’s Disease who have signs and symptoms of cognitive decline. The results of the test are to be interpreted in conjunction with other patient clinical information."},{"c":"SEU","n":"Peripheral Temporary And Retrievable Stent System","k":"2","r":"870.5110","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment."},{"c":"SEW","n":"Automated Endoscope Channel Cleaner","k":"2","r":"880.6994","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization."},{"c":"SEZ","n":"Radiological Software Device To Predict Future Breast Cancer Risk","k":"2","r":"892.8500","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patient’s future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams."},{"c":"SFA","n":"Prosthesis, Finger, Semi-Constrained, Metal/Polymer","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis."},{"c":"SFC","n":"Neurologic Disease Risk Assessment Molecular Test","k":"2","r":"866.5850","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information."},{"c":"SFD","n":"In Situ Polymerizing Peripheral Nerve Repair Device","k":"2","r":"882.5270","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":8,"d":"An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries."},{"c":"SFE","n":"Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation","k":"2","r":"876.1500","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor."},{"c":"SFG","n":"Camera, Surgical, Measurement","k":"1","r":"878.4160","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"An adjunctive tool to measure and record a body part’s physical data, such as diameter, surface area, volume, and perimeter/circumference. The device does not provide a diagnosis or therapy."},{"c":"SFH","n":"Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis","k":"2","r":"864.3755","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A pathology software algorithm device analyzing digital images for prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis."},{"c":"SFI","n":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA."},{"c":"SFJ","n":"Vagus Nerve Stimulator For Rheumatoid Arthritis","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Implantable vagus nerve stimulator for Rheumatoid Arthritis"},{"c":"SFK","n":"Respiratory Effort Belt For Polysomnography","k":"2","r":"882.1400","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems."},{"c":"SFL","n":"Nucleic Acid Based Assay, Microsatellite Instability","k":"3","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":0,"d":"The microsatellite instability (MSI) companion diagnostic is nucleic acid based (molecular) in vitro diagnostic device intended for the qualitative detection of a panel of molecular biomarkers for identification of MSI in human clinical tissue specimens. It reports MSI status as either Microsatellite Stable (MSS) or Microsatellite Instability-High (MSI-H). The MSI companion diagnostic is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess MSI status which may be associated with a better clinical response to specific FDA approved therapeutic drugs."},{"c":"SFN","n":"Non-Invasive Evoked Response Brain Stimulator","k":"2","r":"882.1860","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response."},{"c":"SFO","n":"Electrode Measurement, Drain Effluent Ph","k":"2","r":"862.1120","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Measurement of drain effluent pH"},{"c":"SFP","n":"Ventilator-Compatible Nebulizer","k":"2","r":"868.5630","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"The device is intended to deliver nebulized medications through a ventilator breathing circuit."},{"c":"SFQ","n":"Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision","k":"2","r":"878.4400","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Surgical device used to dissect cardiac tissue for the implantation and revision of cardiac electrophysiology leads"},{"c":"SFR","n":"Hypertension Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up."},{"c":"SFS","n":"Revumenib Eligibility Detection System","k":"2","r":"864.1885","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the purpose of identifying patients who may benefit from treatment with revumenib, in accordance with the approved therapeutic product labeling."},{"c":"SFU","n":"Glucose Range Monitoring System","k":"2","r":"862.1359","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment."},{"c":"SFV","n":"X-Ray, Computed Tomography, Cone-Beam","k":"2","r":"892.1750","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures."},{"c":"SFW","n":"Cranial Electrotherapy Stimulator For Weight Management","k":"1","r":"876.5984","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"A cranial electrotherapy stimulator for weight management is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin to support weight management in conjunction with diet and exercise. Devices in this classification use a low level of electrical current that is not intended to induce a seizure."},{"c":"SGA","n":"Biothreat Microbial Agent Nucleic Acid Detection Test","k":"2","r":"866.4000","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens."},{"c":"SGB","n":"Pain Assessment Software In Non-Communicative Adults","k":"2","r":"882.1472","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool."},{"c":"SGD","n":"Kit D816v Mutation Detection System","k":"F","r":"","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"A KIT D816V mutation detection system is an in vitro diagnostic test intended for qualitative detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis using nucleic acid amplification and real time detection systems. The KIT D816V mutation detection system is indicated as an aid in the selection of aggressive systemic mastocytosis patients for whom Gleevec® (imatinib mesylate) treatment is being considered."},{"c":"SGE","n":"Extracranial Positional System For A Transcranial Magnetic Stimulation System","k":"2","r":"882.4560","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Intended for spatial positioning and orientation of the treatment coil for transcutaneous magnetic stimulation systems under the supervision of a tracking system."},{"c":"SGF","n":"Dural Arteriovenous Fistula Liquid Embolic","k":"F","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"6","u":"","a":0,"b":0,"e":0,"d":"Indicated for use in the treatment of intracranial dural arteriovenous fistulas."},{"c":"SGG","n":"Mass Spectrometric, Immunoglobulins (G, A, M, D, E)","k":"2","r":"866.5510","p":"IM","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods."},{"c":"SGH","n":"Ultrasound Imaging For Vascular Access For Hemodialysis","k":"2","r":"892.1560","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Ultrasound imaging for vascular access for hemodialysis"},{"c":"SGJ","n":"Ultrasound Imaging System For Acquiring Images At Home By Lay Users","k":"2","r":"892.1590","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition."},{"c":"SGK","n":"Prosthesis, Spinous Process Tension Band Implant","k":"3","r":"","p":"OR","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression."},{"c":"SGL","n":"Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant","k":"2","r":"888.4520","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use."},{"c":"SGN","n":"High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation","k":"2","r":"882.4420","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling."},{"c":"SGO","n":"Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures","k":"2","r":"870.1254","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure"},{"c":"SGQ","n":"Intraoral Phototherapy Device","k":"2","r":"872.5595","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis."},{"c":"SGR","n":"Noninvasive Positive Airway Pressure System, Facility Use","k":"2","r":"868.5895","p":"AN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure."},{"c":"SGS","n":"Deep Brain Stimulation For The Treatment Of Dystonia","k":"3","r":"","p":"NE","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"To stimulate deep brain structure to manage dystonia symptoms"},{"c":"SGT","n":"Electromagnetic Stimulator For Healthy Muscle Stimulation","k":"2","r":"890.5850","p":"PM","g":"N","l":"N","i":"N","t":"Y","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions."},{"c":"SGU","n":"Neurovascular Liquid Embolic Agent","k":"3","r":"","p":"NE","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":3,"e":0,"d":"Arterial occlusion of the middle meningeal artery for treatment of symptomatic subdural hematoma."},{"c":"SGV","n":"Agent, Absorbable Hemostatic, Collagen With Polymeric Additives","k":"3","r":"878.4490","p":"SU","g":"N","l":"N","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood."},{"c":"SGW","n":"Device To Detect Antibodies To Hepatitis D Virus","k":"2","r":"866.3176","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The device to detect antibodies to hepatitis D Virus is an in vitro diagnostic device intended for prescription use for the detection of antibodies to the hepatitis D virus (anti-HDV) in human clinical specimens. The assay is intended as an aid in the diagnosis of HDV infection in individuals who are at risk for HDV infection. The assay is intended as an aid in diagnosis in conjunction with clinical findings and other diagnostic procedures. The assay is not intended for screening of blood, plasma, cells, or tissue donors."},{"c":"SGX","n":"Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves","k":"2","r":"880.6512","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An ultraviolet light-based microbial reduction device for luer-activated valves is a device that uses ultraviolet light to irradiate luer-activated valves (e.g., as used for intravascular administration). The device is intended to supplement the manual, physical microbicidal treatment of luer-activated valves by providing limited microbial reduction, and is not intended to disinfect or replace manual microbicidal treatment."},{"c":"SGY","n":"Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant","k":"2","r":"876.5881","p":"GU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This generic type of device may also include perfusion sets, oxygenators, and other components of the perfusion circuit."},{"c":"SGZ","n":"Ultraviolet Lamp Products","k":"2","r":"878.4635","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An ultraviolet lamp product intended to stimulate the production of Vitamin D"},{"c":"SHA","n":"Solid Wound Dressing With Permanently Bound Antimicrobial Agent","k":"2","r":"878.4013","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls."},{"c":"SHB","n":"Creatinine Test System For At Home Prescription Use","k":"2","r":"862.1225","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only."},{"c":"SHC","n":"Low Electric Field Generator For Pancreatic Cancer Treatment","k":"3","r":"","p":"SU","g":"N","l":"Y","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended to treat pancreatic cancer through delivery of low electric fields in patients receiving concomitant systemic therapies or other standard of care treatment(s)"},{"c":"SHE","n":"Radiological Software System For Delivery Date Prediction","k":"2","r":"892.8200","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A radiological software system for delivery date prediction is a software-only device that analyzes obstetric radiological images to predict the delivery date of a pregnancy. The device output does not replace a clinician's review or judgment on the progression of a pregnancy and should be used in conjunction with other clinical and diagnostic findings. The device does not identify at-risk pregnancies or identify specific complications."},{"c":"SHH","n":"Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer","k":"3","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy)."},{"c":"SHI","n":"Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter","k":"2","r":"872.3660","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":4,"b":0,"e":0,"d":"An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards."},{"c":"SHJ","n":"Thrombectomy Whole Blood Return System","k":"2","r":"868.5830","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Filtration and return of aspirated whole blood during a thrombectomy procedure"},{"c":"SHL","n":"Ear, Nose, And Throat Image Analyzer","k":"2","r":"874.4775","p":"EN","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions."},{"c":"SHM","n":"Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe","k":"2","r":"880.6891","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. “Safe to handle” is limited in scope to mean the device has been appropriately intermediate-level disinfected."},{"c":"SHN","n":"Calibration Software For Radiology Displays","k":"1","r":"892.1940","p":"RA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"4","u":"","a":1,"b":0,"e":0,"d":"The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology."},{"c":"SHO","n":"Parkinsonian Syndrome Diagnostic Aid","k":"2","r":"882.2000","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A Parkinsonian syndrome diagnostic aid is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. This device is intended for adjunctive use and not intended as a stand-alone diagnostic."},{"c":"SHP","n":"Cardiac Amyloidosis Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up."},{"c":"SHQ","n":"Dental Image Analyzer, In-Office","k":"2","r":"872.1770","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions."},{"c":"SHR","n":"Device For Open Surgical Explant Of Endovascular Prostheses","k":"2","r":"870.4520","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device is a non-implantable mechanical surgical tool to aid in the open surgical removal of endovascular prostheses in blood vessels."},{"c":"SHU","n":"Appendiceal Scope And Accessories, Flexible","k":"2","r":"876.1500","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix. Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope. Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall."},{"c":"SHV","n":"Reusable Intermittent Urinary Catheter System","k":"2","r":"876.5120","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A reusable intermittent urinary catheter system consists of a reusable intermittent urinary catheter inserted through the urethra into the bladder for urine drainage and the components necessary to reprocess the intermittent catheter. The reusable intermittent urinary catheter can be reused after reprocessing (e.g., cleaning and disinfection) with the components necessary to reprocess the intermittent catheter. The system may include cleaning and microbicidal agents, lubricant and disposable components. The reusable intermittent catheter and any reusable reprocessing components are intended for single patient reuse."},{"c":"SHW","n":"Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis","k":"2","r":"864.3755","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":2,"b":0,"e":0,"d":"A pathology software algorithm device analyzing digital images for breast cancer prognosis is a software intended to analyze digital images acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis."},{"c":"SHX","n":"Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms","k":"2","r":"882.5807","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A transcranial nerve stimulation device for the treatment of post-traumatic stress disorder (PTSD) associated symptoms is a prescription, home-use, externally worn device that applies electrical stimulation to a location on the patient’s head. The device is not intended as a stand-alone therapy or to alter usual care treatment."},{"c":"SHY","n":"Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.","k":"2","r":"878.1840","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device."},{"c":"SIA","n":"Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test","k":"2","r":"866.3984","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments."},{"c":"SIB","n":"Tempo Pilot Eckm: Early Cardio-Kidney-Metabolic","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"TEMPO Pilot: early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes)"},{"c":"SIC","n":"Tempo Pilot Ckm: Cardio-Kidney-Metabolic","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"TEMPO Pilot: cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease)"},{"c":"SID","n":"Tempo Pilot Msk: Musculoskeletal","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"TEMPO Pilot: musculoskeletal (chronic musculoskeletal pain)"},{"c":"SIE","n":"Tempo Pilot Bh: Behavioral Health","k":"N","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"7","u":"6","a":0,"b":0,"e":0,"d":"TEMPO Pilot: behavioral health (depression or anxiety)"},{"c":"SIF","n":"Software Device System For Estimation Of Cardiac Pressures","k":"2","r":"870.1150","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This prescription-only device uses machine learning-based algorithms to analyze one or more non-invasive physiologic signals or parameters to estimate a cardiac pressure (e.g. pulmonary capillary wedge pressure, left ventricular end diastolic pressure, or pulmonary artery pressure.) This device is intended for adjunctive use with patient information and is not intended to independently direct therapy. The device may contain hardware sensors. This device is not intended to estimate systemic, vascular blood pressure."},{"c":"SIG","n":"Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)","k":"2","r":"882.5802","p":"NE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields in brain areas outside cerebral cortex (e.g., cerebellum)."},{"c":"SIH","n":"Device For Home Collection And Transport Of Specimens By Lay Users For Use In A Cleared Non-Viral Sti Molecular Assay","k":"2","r":"866.2920","p":"MI","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A device for home collection and transport of specimens by lay users for use in a cleared non-viral STI molecular assay is a device intended for use by lay users in home settings or similar environments for the collection and transportation of specimens for testing using a cleared non-viral STI molecular assay with which the device has been validated."},{"c":"SII","n":"Aortic Stenosis Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Aortic Stenosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of aortic stenosis for further referral or diagnostic follow-up."},{"c":"SIJ","n":"Valvular Regurgitation Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Valvular regurgitation machine learning-based notification software employs machine learning techniques to suggest the likelihood of valvular regurgitation for further referral or diagnostic follow-up."},{"c":"SIK","n":"Cardiac Hypertrophy Machine Learning-Based Notification Software","k":"2","r":"870.2380","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":0,"b":0,"e":0,"d":"Cardiac hypertrophy machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac hypertrophy for further referral or diagnostic follow-up."},{"c":"SIL","n":"Wound Dressings Containing Oxygen","k":"U","r":"","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"1","a":3,"b":0,"e":0,"d":"A wound dressing containing oxygen is intended to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound."},{"c":"SIM","n":"Gynecologic Power Morcellator And Containment System","k":"2","r":"884.4075","p":"OB","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A gynecologic power morcellator and containment system is a prescription device consisting of an integrated power morcellator and a containment method that are intended to contain, reduce and remove gynecologic tissue that is not suspected to contain malignancy during minimally invasive surgery."},{"c":"SIN","n":"Automated Intraoperative Spinal Rod Bending System","k":"2","r":"888.3070","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod."},{"c":"SIO","n":"Test For Esophageal Varices","k":"3","r":"","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"A Test for Esophageal Varices is a quantitative test that measures cholate concentrations in human specimens and uses the cholate concentrations to generate a score. The score is used to identify patients unlikely to have large esophageal varices and unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing."},{"c":"SIQ","n":"Intra-Articular Orthopedic Stereotaxic Navigation Instrument","k":"2","r":"888.4561","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An intra-articular orthopedic stereotaxic navigation instrument is a device consisting of a rigid frame of reference with a calibrated guide mechanism and fiducial markers temporarily affixed to anatomical structures within the intraarticular space. The markers are continuously tracked for precisely positioning instruments or other devices."},{"c":"SIR","n":"Integrated Operating Table-Electromechanical Surgical System","k":"2","r":"878.4966","p":"SU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform."},{"c":"SIT","n":"Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System","k":"2","r":"888.1150","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices."},{"c":"SIU","n":"Predictive Indicator For Long-Term Cardiovascular Outcomes","k":"2","r":"870.2215","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease."},{"c":"SIW","n":"Robotic Peripheral Venous Blood Collection System","k":"2","r":"880.6975","p":"HO","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A robotic peripheral venous blood collection system is an electromechanical device used to obtain blood samples from peripheral veins for diagnostic purposes. The device uses robotic systems to assist with the blood collection procedure, including vessel identification, targeting, and/or needle insertion, and may perform its functions in an automated or autonomous manner."},{"c":"SIX","n":"Digital Pathology Image Artifact Detection Software Device","k":"2","r":"864.3700","p":"PA","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"Digital Pathology Image Artifact Detection Software device is an artificial intelligence-based software intended to identify specific artifacts in scanned digital whole slide images (WSIs) of pathology slides prepared from human samples. It is intended to identify WSIs that should undergo further evaluation for image quality prior to diagnostic review of the images by pathologists. Device output is not intended for use in diagnosis, prognosis, or prediction of disease."},{"c":"SJA","n":"Injectable For Thermal Treatment Of Musculoskeletal Pain","k":"2","r":"888.3048","p":"OR","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An injectable for thermal treatment of musculoskeletal pain is an injectable device intended to inhibit sensory nerve signaling through exchange of thermal energy (e.g., cold temperatures). The device is injected into the extraneural space of the target nerve."},{"c":"SJB","n":"Powered Fecal Management System","k":"2","r":"876.5230","p":"GU","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment."},{"c":"SJD","n":"Integrated Continuous Glucose Ketone Monitoring System","k":"2","r":"862.1354","p":"CH","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"An integrated continuous glucose ketone monitoring system (iCGK) is intended to automatically measure glucose and ketones in bodily fluids continuously or frequently for a specified period of time. iCGK systems are designed to reliably and securely transmit glucose and ketone measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control or ketone fluctuation. When making therapeutic adjustments, ketone output should be used in conjunction with glucose levels, symptoms, and factors that may affect ketone levels such as eating patterns and exercise."},{"c":"SJH","n":"Portable Dental Operative Unit","k":"1","r":"872.6640","p":"DE","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A portable dental operative unit is a device intended to serve as a base station for dental instruments and accessories, delivering utilities such as compressed air, water, suction, and power to handheld dental instruments. The device is designed for use in non-permanent healthcare environments, including dental clinics, hospitals, mobile clinics, long-term care facilities, patient residences, schools, correctional facilities, military or humanitarian field settings, and similar settings, by dental professionals."},{"c":"SJJ","n":"Cardiac Device Identifier","k":"2","r":"870.3645","p":"CV","g":"N","l":"N","i":"N","t":"N","m":"Ineligible","s":"1","u":"","a":1,"b":0,"e":0,"d":"A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals, including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation to, modify the programming of, or manipulate the stored data of the implanted device."},{"c":"SJL","n":"Heart-Valve, Polymeric","k":"3","r":"","p":"CV","g":"N","l":"Y","i":"Y","t":"N","m":"Ineligible","s":"2","u":"","a":0,"b":1,"e":0,"d":"This device is a permanent implant intended to replace a heart valve."}]}