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U.S. Department of Health and Human Services

Medical Devices

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List 2 - Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Now Require the Submission of Validation

(From September 29, 2005, Federal Register Notice)

21 CFR No.Classification NameProduct Code for Nonreprocessed DeviceProduct Code for Reprocessed DeviceProduct Code Name for Reprocessed Device
UnclassifiedOocyte Aspiration NeedlesMHKNMOOocyte Aspiration Needles
UnclassifiedPercutaneous Transluminal Angioplasty CatheterLITNMMTransluminal Peripheral Angioplasty Catheter
UnclassifiedUltrasonic Surgical InstrumentLFLNLQUltrasonic Scalpel
868.5150Anesthesia Conduction NeedleBSPNNHAnesthetic Conduction Needle (with/without Introducer)
868.5150Anesthesia Conduction NeedleMIANMRShort Term Spinal Needle
868.5730Tracheal TubeBTRNMATracheal Tube (with/without connector)
868.5905Noncontinous Ventilator (IPPB)BZDNMCNoncontinuous Ventilator (Respirator Mask)
870.1200Diagnostic Intravascular CatheterDQONLIAngiography Catheter
870.1220Electrode Recording CatheterDRFNLHElectrode Recording Catheter
870.1220Electrode Recording CatheterMTDNLGIntracardiac Mapping Catheter
870.1230Fiberoptic Oximeter CatheterDQENMBFiberoptic Oximeter Catheter
870.1280Steerable CatheterDRANKSSteerable Catheter
870.1290Steerable Catheter Control SystemDXXNKRSteerable Catheter Control System
870.1330Catheter Guide WireDQXNKQCatheter Guide Wire
870.1390TrocarDRCNMKCardiovascular Trocar
870.1650Angiographic Injector and SyringeDXTNKTAngiographic Injector and Syringe
870.1670Syringe Actuator for InjectorDQFNKWInjector for Actuator Syringe
870.2700OximeterMUDNMDTissue Saturation Oximeter
870.2700OximeterDQANLFOximeter
870.3535Intra-Aortic Balloon and Control SystemDSPNKOIntra-Aortic Balloon and Control System
870.4450Vascular ClampDXCNMFVascular Clamp
870.4885External Vein StripperDWQNLJExternal Vein Stripper
872.5470Orthodontic Plastic BracketDYWNLCOrthodontic Plastic Bracket
874.4680Bronchoscope (Flexible or Rigid) and AccessoriesBWHNLEBronchoscope (Nonrigid Biopsy Forceps)
876.1075Gastro-Urology Biopsy InstrumentFCGNMXG-U Biopsy Needle and Needle Set
876.1075Gastro-Urology Biopsy InstrumentKNWNLSBiopsy Instrument
876.1500Endoscope and AccessoriesFBK, FHPNMYEndoscopic Needle
876.1500Endoscope and AccessoriesMPANKZEndoilluminator
876.1500Endoscope and AccessoriesGCJNLMGeneral and Plastic Surgery Laparoscope
876.1500Endoscope and AccessoriesFHONLXSpring-Loaded Pneumoperitoneum Needle
876.4300Endoscopic Electrosurgical Unit and AccessoriesFASNLWActive Urological Electrosurgical Electrode
876.4300Endoscopic Electrosurgical Unit and AccessoriesFEHNLVFlexible Suction Coagulator Electrode
876.4300Endoscopic Electrosurgical Unit and AccessoriesKGENLUElectric Biopsy Forceps
876.4300Endoscopic Electrosurgical Unit and AccessoriesFDINLTFlexible Snare
876.4300Endoscopic Electrosurgical Unit and AccessoriesKNSNLREndoscopic (with or without accessories) Electrosurgical Unit
876.5010Biliary Catheter and AccessoriesFGENMLBiliary Catheter
876.5540Blood Access Device and AccessoriesLBWNNFSingle Needle Dialysis Set (co-axial flow)
876.5540Blood Acces Device and AccessoriesFIENNEFistula Needle
876.5820Hemodialysis Systems and AccessoriesFIFNNGSingle Needle Dialysis Set with Uni-Directional Pump
878.4300Implantable ClipFZPNMJImplantable Clip
878.4400Electrosurgical Cutting and Coagulation Device and AccessoriesGEINUJEndoscopic and Laparoscopic Electrosurgical Accessories
878.4750Implantable StapleGDWNLLImplantable Staple
880.5570Hypodermic Single Lumen NeedleFMINKKHypodermic Single Lumen Needle
880.5860Piston SyringeFMFNKNPiston Syringe
882.4300Manual Cranial Drills, Burrs, Trephines and AccessoriesHBGNLO(Manual) Drills, Burrs, Trephines, and Accessories
882.4305Powered Compound Cranial Drills, Burrs, TrephinesHBFNLP(Powered, Compound) Drills, Burrs, Trephines and Accessories
882.4310Powered Simple Cranial Drills, Burrs, TrephinesHBENLN(Simple, Powered) Drills, Burrs, Trephines and Accessories
884.1720Gynecologic Laparoscope and AccessoriesHETNMHGynecologic Laparoscope (and Accessories)
884.6100Assisted Reproduction NeedleMQENNBAssisted Reproduction Needle
886.4370KeratomeHMY, HNONKYKeratome Blade
886.4670Phacofragmentation SystemHQCNKXPhacoemulsification Needle
892.5730Radionuclide Brachytherapy SourceIWFNMPIsotope Needle

Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in "Draft Guidance for Hemodialyzer Reuse Labeling" October 6, 1995. An archived copy may be obtained from CDRH's Division of Small Manufacturers, International, and Consumer Assistance, please contact dsmica@cdrh.fda.gov.