Gauthier Biomedical
Pack of Two G440350 Electronic Torque Indicator pencil grip, Fixed AO pull connect
14manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Shandong (2). 6 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 |
| 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 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
Showing 12 of 14. All 14 manufacturers in China registered for Wrench
Record
| Listed by | Gauthier Biomedical, Inc., United States |
|---|---|
| FDA product code | HXC |
| Device type | Wrench |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-11 |
| Record revised | 2022-05-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G442000 | 2 | In distribution | |
| 5161-00-5020 (GC150086-10) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 85 |
| Wrench | Synthes Gmbh | 80 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
| Smart Correction | Wishbone Medical Inc. | 25 |
| Pinnacle Gription TF | Depuy (Ireland) | 23 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 21 |
| Mega Plus Spine System | BK Meditech Co., Ltd. | 20 |
| Kalitec Universal Instruments | Kalitec Direct, LLC | 19 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 17 |
| X FIX | Biomet Orthopedics | 15 |
| Global Steptech APG | Depuy Orthopaedics, Inc. | 14 |
| Wrench | Zimmer, Inc. | 14 |
Showing 12 of 388. All products under Wrench
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180092 | 2018-03-08 |
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.