Device Class Class- (None) Class-U (Unclassified) Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls.) Class-3 (A medical device with high risk that requires premarket approval)
Product Code BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) (BTG) (4) Tube, tracheal (w/wo connector) (BTR) (6) Needle, emergency airway (BWC) (2) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (109) CANNULA, CATHETER (DQR) (3) WIRE, GUIDE, CATHETER (DQX) (401) Wire, guide, catheter (DQX) (9) CATHETER, PERCUTANEOUS (DQY) (275) Trocar (DRC) (107) DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION (DRE) (127) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (38) CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS (DWF) (1) DEVICE, BIOPSY, ENDOMYOCARDIAL (DWZ) (6) INTRODUCER, CATHETER (DYB) (13) CATHETER, FLOW DIRECTED (DYG) (2) CATHETER, URETERAL, GASTRO-UROLOGY (EYB) (4) CONNECTOR, URETERAL CATHETER (EYK) (4) CATHETER, RETENTION TYPE, BALLOON (EZL) (2) DILATOR, CATHETER, URETERAL (EZN) (13) Stent, ureteral (FAD) (14) CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE (FAP) (18) endoscopic injection needle, gastroenterology-urology (FBK) (25) Trocar, gastro-urology (FBQ) (5) FILIFORM AND FILIFORM FOLLOWER (FBW) (22) Biopsy needle (FCG) (3) FORCEPS, BIOPSY, NON-ELECTRIC (FCL) (2) Urinary drainage collection kit, for indwelling catheter (FCN) (10) SNARE, FLEXIBLE (FDI) (2) endoscopic cytology brush (FDX) (7) TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION (FEG) (2) DEVICE, CYSTOMETRIC, HYDRAULIC (FEN) (2) COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER (FFH) (1) DISLODGER, STONE, BASKET, URETERAL, METAL (FFL) (17) SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) (FFX) (1) CATHETER, BILIARY, DIAGNOSTIC (FGE) (27) Stents, drains and dilators for the biliary ducts (FGE) (44) NEEDLE, GASTRO-UROLOGY (FHR) (2) Needle, hypodermic, single lumen (FMI) (21) Catheter, intravascular, therapeutic, short-term less than 30 days (FOZ) (150) Catheter,intravascular,therapeutic,short-term less than 30 days (FOZ) (100) Set, administration, intravascular (FPA) (1) NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE (GAA) (11) CATHETER, URETERAL, GENERAL & PLASTIC SURGERY (GBL) (28) CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY (GBO) (2) CATHETER, MULTIPLE LUMEN (GBP) (1) CATHETER, PERITONEAL (GBW) (21) CATHETER, IRRIGATION (GBX) (85) CATHETER, CHOLANGIOGRAPHY (GBZ) (8) CATHETER, BILIARY, SURGICAL (GCA) (19) NEEDLE, CATHETER (GCB) (17) Dilator, catheter (GCC) (2) CONNECTOR, CATHETER (GCD) (14) APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED (GCY) (4) GUIDE, NEEDLE, SURGICAL (GDF) (2) BRUSH, DERMABRASION, MANUAL (GED) (1) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (47) Powered laser surgical instrument (GEX) (21) INSTRUMENT, SURGICAL, NON-POWERED (HAO) (2) DILATOR, CERVICAL, FIXED SIZE (HDQ) (2) INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES) (HES) (2) LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) (HET) (4) SOUND, UTERINE (HHM) (1) SCREW, FIBROID, GYNECOLOGICAL (HHO) (1) System, applicator, radionuclide, manual (IWJ) (3) Tube tracheostomy and tube cuff (JOH) (3) CATHETER AND TIP, SUCTION (JOL) (16) TRANSDUCER, ULTRASONIC (JOP) (3) INSTRUMENT, SURGICAL, DISPOSABLE (KDC) (1) ACCESSORIES, CATHETER (KGZ) (49) INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC (KNA) (2) Dilator, esophageal (KNQ) (4) Unit, electrosurgical, endoscopic (with or without accessories) (KNS) (18) TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (26) INSTRUMENT, BIOPSY (KNW) (4) SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) (KOA) (8) CATHETER, SUPRAPUBIC (AND ACCESSORIES) (KOB) (35) CATHETER, UROLOGICAL (KOD) (43) DILATOR, URETHRAL (KOE) (96) Catheter, continuous flush (KRA) (7) Device, Vascular, for Promoting Embolization (KRD) (6) BRONCHOSCOPE ACCESSORY (KTI) (3) CATHETER, NEPHROSTOMY (LJE) (89) Cannula, manipulator/injector, uterine (LKF) (7) CATHETER, SAMPLING, CHORIONIC VILLUS (LLX) (2) DISLODGER, STONE, BILIARY (LQR) (3) INSTRUMENT, ENT MANUAL SURGICAL (LRC) (6) Syringe, balloon inflation (MAV) (2) CANNULA, INTRAUTERINE INSEMINATION (MFD) (1) NEEDLE, TUMOR LOCALIZATION (MIJ) (5) DEVICE, PERCUTANEOUS, BIOPSY (MJG) (77) Catheters, salpingography (MOV) (1) CATHETER, HEMODIALYSIS, NON-IMPLANTED (MPB) (3) NEEDLE, ASSISTED REPRODUCTION (MQE) (71) CATHETER, ASSISTED REPRODUCTION (MQF) (1) ACCESSORY, ASSISTED REPRODUCTION (MQG) (4) MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) (MQH) (20) AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS (NAJ) (2) CEMENT, BONE, VERTEBROPLASTY (NDN) (1) Endoscopic Cholangiogram Kit (NWT) (1) Endoscopic guidewire, gastroenterology-urology (OCY) (43) Endoscopic grasping/cutting instrument, non-powered (OCZ) (5) Endoscope channel accessory (ODC) (6) Cardiovascular procedure kit (OEZ) (2) Catheter, balloon, dilation of cervical canal prior to labor (PFJ) (2) esophageal dilator balloon with or without electrode sensors (PID) (2) Retrograde intubation set (QCX) (3)