Tecomet
VOLKMAN Retractor.8 1/2" 3 PRONG BLADE RING HANDLE
34manufacturers in China registered for this device type
87catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Tecomet, Inc., United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-15 |
| Record revised | 2024-01-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-06-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KMPR1725 | In distribution | |
| KMPR1292 | In distribution | |
| 00481300600 | In distribution | |
| 00481302402 | In distribution | |
| 2560-10-000 | In distribution | |
| 2181-12-000 | In distribution | |
| 2160-00-000 | In distribution | |
| 2810-22-000 | In distribution | |
| 2577-00-000 | In distribution | |
| KMPR530 | In distribution | |
| KMPR1296 | In distribution | |
| KMPR708 | In distribution | |
| 2598-07-260 | In distribution | |
| 2598-07-300 | In distribution | |
| 55908 | In distribution | |
| 2131-10-000 | In distribution | |
| 2485-00-000 | In distribution | |
| 2131-12-000 | In distribution | |
| 00481301801 | In distribution | |
| AR-8943-22 | In distribution | |
| PR52682 | In distribution | |
| KMPR3857 | In distribution | |
| 52272 | In distribution | |
| 2181-06-000 | In distribution | |
| PR51468B | In distribution | |
| 00481300800 | In distribution | |
| 2590-00-000 | In distribution | |
| 374106 | In distribution | |
| KMPR6532-04 | In distribution | |
| 2586-14-000 | In distribution | |
| 2576-12-000 | In distribution | |
| 804-00-203 | In distribution | |
| 47482 | In distribution | |
| KMPR705 | In distribution | |
| 61261 | In distribution | |
| KMPR3849 | In distribution | |
| 46823 | In distribution | |
| 804-00-202 | In distribution | |
| 2560-12-000 | In distribution | |
| 00481301500 | In distribution | |
| 2556-12-000 | In distribution | |
| KMPR533 | In distribution | |
| 2579-12-000 | In distribution | |
| KMPR1293 | In distribution | |
| 2810-24-000 | In distribution | |
| KMPR531 | In distribution | |
| 52268 | In distribution | |
| 51772 | In distribution | |
| 2344-14-000 | In distribution | |
| 46850 | In distribution | |
| 2576-10-000 | In distribution | |
| 2131-16-000 | In distribution | |
| 2131-14-000 | In distribution | |
| 2160-00-000 | In distribution | |
| 55904 | In distribution | |
| 2004-00-000 | In distribution | |
| 51776 | In distribution | |
| 52532 | In distribution | |
| AR-13225 | In distribution | |
| 52474 | In distribution | |
| 2585-14-000 | In distribution | |
| KMPR1299 | In distribution | |
| 51768 | In distribution | |
| 2557-00-000 | In distribution | |
| 52486 | In distribution | |
| 2630-10-000 | In distribution | |
| PR52682-1 | In distribution | |
| 2556-10-000 | In distribution | |
| KMPR1290 | In distribution | |
| KMPR1295 | In distribution | |
| 51770 | In distribution | |
| PR51468A | In distribution | |
| 00481300801 | In distribution | |
| 46838 | In distribution | |
| 47527 | In distribution | |
| 52494 | In distribution | |
| AR-8943-21 | In distribution | |
| 00481607000 | In distribution | |
| 2181-14-000 | In distribution | |
| 52276 | In distribution | |
| 52274 | In distribution | |
| 2598-07-200 | In distribution | |
| 47384 | In distribution | |
| 2181-10-000 | In distribution | |
| 52490 | In distribution | |
| KMPR534 | In distribution | |
| 2245-10-022 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.