Gauthier Biomedical
This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to shaft type instruments, such as awls, taps, screw drivers and similar instruments used by a…
This hand – held, orthopedic, manual, surgical instrument handle is designed to connect to shaft type instruments, such as awls, taps, screw drivers and similar instruments used by a surgeon to prepare fasteners or constructs for installation, driving or adjusting fasteners or to perform manipulations during surgery. This is a reusable device.
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Gauthier Biomedical, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-11 |
| Record revised | 2024-04-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G207165 | In distribution | |
| G852402 | In distribution | |
| G415163 | In distribution | |
| G900100 | In distribution | |
| G851204 | In distribution | |
| G207163 | In distribution | |
| 5161-00-5017 (G901553) | In distribution | |
| G851301 | In distribution | |
| G601050 | In distribution | |
| G207166 | In distribution | |
| G107212 | In distribution | |
| 5161-00-5091 (G901021) | In distribution | |
| 6231-31-022 (G700206) | In distribution | |
| G602050 | In distribution | |
| OH001 | In distribution | |
| AR-7801 | In distribution | |
| 5161-00-5011(G900036) | In distribution | |
| G900037 | In distribution | |
| G901022 | In distribution | |
| G412163 | In distribution | |
| G412162 | In distribution | |
| G852404 | In distribution | |
| G911000 | In distribution | |
| 5161-00-5048 (G919509) | In distribution | |
| GC100184 | In distribution | |
| G900000 | In distribution | |
| GC101211 | In distribution | |
| G914559 | In distribution | |
| 254600410 | In distribution | |
| G178104 | In distribution | |
| G109800 | In distribution | |
| G912126 | In distribution | |
| 5161-00-5013 (G913557) | In distribution | |
| AR-9091-32 | In distribution | |
| G307407 | In distribution | |
| G851100 | In distribution | |
| G912111 | In distribution | |
| G700251 | In distribution | |
| AR-9091-26 | In distribution | |
| G900021 | In distribution | |
| 5161-00-5010 (G914562) | In distribution | |
| 5161-00-5012 (G912118) | In distribution | |
| G412161 | In distribution | |
| G170059 | In distribution | |
| 5161-00-5047(G919508) | In distribution | |
| G851200 | In distribution | |
| G912128 | In distribution | |
| 5161-00-5014 (G902564) | In distribution | |
| G817562 | In distribution | |
| G178101 | In distribution | |
| 5161-00-5015 (G916124) | In distribution | |
| G119402 | In distribution | |
| G850000 | In distribution | |
| G170402 | In distribution | |
| GC101210 | In distribution | |
| G851100 – 2Nm version | In distribution | |
| GC100185 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Gauthier Biomedical, Inc. | UDI-DI | 2024-11-11 | Class II | Process change control | An out of specification component may result in the device exhibiting torque output higher than the design specification. | 160 units |
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.