Gsource
Combination Wire Cutter DA and Twister 9", serr jaw 8mm, TC, max cap 1.6mm [.062”]
3manufacturers in China registered for this device type
22catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | HXS |
| Device type | Twister, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-27 |
| Record revised | 2022-08-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| gS 82.4278 | In distribution | |
| gS 82.4260 | In distribution | |
| gS 78.9116 | In distribution | |
| gS 82.4263 | In distribution | |
| gS 78.9112 | In distribution | |
| gS 82.4275 | In distribution | |
| gS 78.9118 | In distribution | |
| gS 82.4255 | In distribution | |
| gS 78.9114 | In distribution | |
| gS 78.9118 | In distribution | |
| gS 82.4282 | In distribution | |
| gS 82.4280 | In distribution | |
| gS 82.4790 | In distribution | |
| gS 82.4264 | In distribution | |
| gS 78.9116 | In distribution | |
| gS 78.9110 | In distribution | |
| gS 79.2003 | In distribution | |
| gS 82.4281 | In distribution | |
| gS 82.4302 | In distribution | |
| gS 82.4270 | In distribution | |
| gS 78.9114 | In distribution | |
| gS 78.9110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Forceps | KLS-Martin L.P. | 13 |
| Twister, Wire | Biomet Microfixation | 12 |
| Orthomed | Ortho-MED, Inc. | 12 |
| NewPort | Seaspine Orthopedics Corporation | 12 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| Ambler Surgical | Ambler Surgical, LLC | 10 |
| Sklar® | Sklar Corporation | 9 |
| Millennium | Avalign Technologies, Inc. | 8 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 7 |
| Kmedic | Teleflex Medical LLC | 7 |
| Malibu | Seaspine Orthopedics Corporation | 7 |
Showing 12 of 57. All products under Twister, Wire
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.