FDA Device Registration & Listing · Mc Lean, VA, US · Registration 3009049852
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-01-18 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2015-12-28 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2013-03-07 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2015-12-28 |
| EMD | Hemostat, Surgical | Dental | Class 1 | 872.4565 | 2015-12-28 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2015-12-28 |
| ELA | Instrument, Hand, Calculus Removal | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2015-12-28 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2015-12-28 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2015-12-28 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2016-01-18 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2016-01-18 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2015-12-28 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2016-01-18 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2016-01-18 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2016-01-18 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-01-18 |
No US Agent registered (Local establishment).
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0012-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Carbon Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0013-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| 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 |
|---|---|---|
| 3009154535 | WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD. | Wenzhou City Zhejiang, CN |
| 8010379 | DEPUY INTL., LTD. | LEEDS, GB |
| 3011534620 | TURNXON PRECISION CO., LTD | Dongguan Guangdong, CN |
| 3007751820 | ALVI Expo | Sialkot Punjab, PK |
| 8010257 | HERMANN MEDIZINTECHNIK GMBH | FRIDINGEN Baden-Wurttemberg, DE |
3009049852 when referencing this establishment in official correspondence.