FDA Device Registration & Listing · CHENNAI, Tamil Nadu, IN · Registration 9613926
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2007-11-13 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2003-07-17 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2003-07-17 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2007-11-14 |
| GCZ | Retainer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KCM | Dropper, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2007-11-14 |
| FXE | Speculum, Non-Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2007-11-14 |
| KCA | Tonsillectome | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| FXF | Speculum, Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2007-11-14 |
| HRP | Pen, Marking, Surgical | Ophthalmic | Class 1 | 886.4570 | 2007-11-15 |
| FEX | Instrument, Catheter, Punch | Gastroenterology, Urology | Class 1 | 876.5090 | 2007-11-14 |
| NNN | Crimper, Wire, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-11-09 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2003-07-17 |
| KCE | Cannulae, Bronchial | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2007-11-13 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| JYS | Perforator, Ear-Lobe | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| NNS | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-11-09 |
| KAG | Holder, Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2002-08-28 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| KCF | Dilator, Esophageal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2003-07-17 |
| FFF | Cover, Biopsy Forceps | Gastroenterology, Urology | Class 1 | 876.1075 | 2007-11-14 |
| MJG | Device, Percutaneous, Biopsy | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2007-11-13 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| MZY | Graft, Vascular, Stainless Steel Tunneler | Cardiovascular | Class 2 | 870.3450 | 2007-11-13 |
| GXL | Screwdriver, Skullplate | Neurology | Class 1 | 882.4900 | 2007-11-10 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| GXJ | Punch, Skull | Neurology | Class 1 | 882.4750 | 2007-11-10 |
| JZC | Searcher, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| LRD | Applicator, Ent Drug | Ear, Nose, Throat | Class 1 | 874.5220 | 2007-11-14 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2007-11-15 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| NOI | Stand, Instrument, Ophthalmic, Battery Powered | Ophthalmic | Class 1 | 886.1860 | 2007-11-10 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| FXG | Specula Accessories | General, Plastic Surgery | Class 1 | 878.1800 | 2007-11-14 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2003-07-17 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| JXY | Jig, Piston Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2002-08-28 |
| FRI | Scale, Stand-On, Patient | General Hospital | Class 1 | 880.2700 | 2007-11-15 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| HBX | Instrument, Cranioplasty Material Forming | Neurology | Class 1 | 882.4500 | 2007-11-10 |
| HWP | Punch, Femoral Neck | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| HBM | Headrest, Neurosurgical | Neurology | Class 1 | 882.4440 | 2003-07-17 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2003-07-17 |
| KAT | Perforator, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-09 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KBF | Trephine, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| EPP | Splint, Nasal | Ear, Nose, Throat | Class 1 | 874.5800 | 2007-11-14 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| JYC | Cannula, Ear | General, Plastic Surgery | Class 1 | 878.4800 | 2002-08-28 |
| GFB | Head, Surgical, Hammer | General, Plastic Surgery | Class 1 | 878.4820 | 2007-11-14 |
| NNT | Punch, Gelfoam, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-11-09 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2007-11-13 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2003-07-17 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2002-08-28 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2007-11-15 |
| KBP | Hook, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2002-08-28 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| EKF | Instrument, Contouring, Matrix, Operative | Dental | Class 1 | 872.4565 | 2007-11-13 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2007-11-13 |
| JYJ | Gauge, Measuring | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2007-11-13 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KAX | Punch, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-09 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| EJZ | Knife, Margin Finishing, Operative | Dental | Class 1 | 872.4565 | 2007-11-13 |
| HXQ | Crimper, Pin | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2007-11-15 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| HXR | Spatula, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| EKD | Instrument, Cutting, Operative | Dental | Class 1 | 872.4565 | 2003-07-17 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| JYP | Knife, Myringotomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JYM | Inserter, Myringotomy Tube | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| KCN | Ear Wick | Ear, Nose, Throat | Class 1 | 874.5220 | 2002-08-28 |
| JYE | Chisel, Middle-Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| KBT | Punch, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2007-11-13 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2002-08-28 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2002-08-28 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1998-03-12 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2007-11-13 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2007-11-15 |
| HTT | Burr, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| FQA | Scale, Surgical Sponge | General Hospital | Class 1 | 880.2740 | 2007-11-15 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2003-07-17 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2007-11-15 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2002-08-28 |
| MMO | Tray, Surgical, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-09 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2007-11-13 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| JYI | Gauge, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2003-07-17 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| FZR | Contractor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| NNO | Jig, Piston Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-11-09 |
| KBG | Trocar, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| JYD | Chisel, Mastoid | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-11-12 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KAZ | Rasp, Frontal-Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-09 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| FJY | Plier, Crimp | Gastroenterology, Urology | Class 1 | 876.5540 | 2007-11-14 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-07-17 |
| HWD | Starter, Bone Screw | Orthopedic | Class 1 | 888.4540 | 2003-07-17 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2007-11-13 |
| JZD | Snare, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-08-28 |
| GAE | Snare, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| KAR | Irrigator, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-07 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| LWF | Dilator, Nasal | Ear, Nose, Throat | Class 1 | 874.3900 | 2002-08-28 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2007-11-09 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| HXE | Fork | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-14 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2007-11-13 |
| LCN | Scraper, Tongue | Dental | Class 1 | 872.6855 | 2007-11-14 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2007-11-10 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-11-13 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2007-11-13 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 2015-08-27 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0021-2015 | Biomet, Inc. | 1 | Compress Face Reamer
Product Usage:
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. |
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Z-0025-2011 | Medical Device Technologies, Inc. | 1 | Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows:
Model Number: 763114100X
Lot #'s:
92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M.
Model Number: 763114160X
Lot #'s
92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ.
Model Number: 763114200X
Lot #'s
92661WY0, 00751ZYJ, 012420U1
Model Number: 763116100X
Lot #'s
92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3.
Model Number: 763116160X
Lot #'s
92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS
Model Number: 763116200X
Lot #'s
121KN
Model Number: 763116200X
Lot #'s
92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT
Model Number: 763118100X
Lot #'s
92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX.
Model Number: 763118160X
Lot #s
92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO.
Model Number: 763118200X
Lot #s
92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I.
Model Number: 763120100X
Lot #s
93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF.
Model Number: 763120160X
Lot #s
92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8.
Model Number: 763120200X
Lot #s
00351Z85, 012020QG, 012420TW.
Model Number: 763418200X
Lot #s
92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6.
Model Number: 763418250X
Lot #s
92751X60, 00671ZRL,
Model Number: 763418250X
Lot #s
92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0. |
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8010732 | Kohler Medizintechnik GmbH | STOCKACH Baden-Wurttemberg, DE |
| 3008711893 | B.Braun Medical (Suzhou) Co,.Ltd | Suzhou Jiangsu, CN |
| 1646747 | WEXLER SURGICAL, INC. | HOUSTON, TX, US |
| 3010687973 | FETZER SURGICAL, LLC | Scottsdale, AZ, US |
| 3016965929 | COMFORT SURGICAL INSTRUMENTS | Sialkot Punjab, PK |
9613926 when referencing this establishment in official correspondence.