Gsource
gSilicone Brain Spatula 7", x-large, 14mm/25mm, malleable, copper, silicone coated, black
4manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | HXR |
| Device type | Spatula, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-19 |
| Record revised | 2022-08-17 (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 37.0043 | In distribution | |
| gS 42.6223 | In distribution | |
| gS 37.0049 | In distribution | |
| gS 42.6222 | In distribution | |
| gS 42.6020 | In distribution | |
| gS 42.6305 | In distribution | |
| gS 37.0047 | In distribution | |
| gS 42.6316 | In distribution | |
| gS 37.1006 | In distribution | |
| gS 42.5950 | In distribution | |
| gS 37.0046 | In distribution | |
| gS 42.5980 | In distribution | |
| gS 42.6224 | In distribution | |
| gS 42.6120 | In distribution | |
| gS 42.6220 | In distribution | |
| gS 37.0045 | In distribution | |
| gS 37.1009 | In distribution | |
| gS 37.0048 | In distribution | |
| gS 42.6121 | In distribution | |
| gS 37.0042 | In distribution | |
| gS 42.6317 | In distribution | |
| gS 37.0044 | In distribution | |
| gS 42.6221 | In distribution | |
| gS 37.1014 | In distribution | |
| gS 42.6306 | In distribution | |
| gS 37.1011 | In distribution | |
| gS 42.6225 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kohdent | Kohler Medizintechnik GmbH | 10 |
| Hunter | Wright Medical Technology, Inc. | 9 |
| Custom | Medicrea International | 7 |
| Rema Shaver Blades | Dewimed Medizintechnik Gmbh | 7 |
| Pass LP | Medicrea International | 5 |
| P.l.u.s.® | Spinevision SAS | 5 |
| Hayden Medical | Hayden Medical Inc | 3 |
| Inka | The Trustee for Kaiser Family Trust | 2 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 2 |
| Gill | The Radebaugh-Fetzer Company | 1 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 1 |
| Spatula, Orthopedic | Spinevision SAS | 1 |
Showing 12 of 19. All products under Spatula, Orthopedic
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.