Gsource
Rumel Dissecting Fcps 9", slight cvd, lateral serr
6manufacturers in China registered for this device type
43catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (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 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | DWS |
| Device type | Instruments, Surgical, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-19 |
| Record revised | 2022-08-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| gS 22.2580 | In distribution | |
| gS 22.8662 | In distribution | |
| gS 22.2655 | In distribution | |
| gS 22.1759 | In distribution | |
| gS 22.2620 | In distribution | |
| gS 22.2657 | In distribution | |
| gS 22.2060 | In distribution | |
| gS 22.8480 | In distribution | |
| gS 22.9160 | In distribution | |
| gS 22.8484 | In distribution | |
| gS 22.7706 | In distribution | |
| gS 22.8482 | In distribution | |
| gS 22.1760 | In distribution | |
| gS 22.8424 | In distribution | |
| gS 22.4080 | In distribution | |
| gS 22.2080 | In distribution | |
| FH.22.2580 | In distribution | |
| gS 22.2960 | In distribution | |
| gS 22.8660 | In distribution | |
| gS 22.4020 | In distribution | |
| gS 22.7702 | In distribution | |
| gS 22.1758 | In distribution | |
| gS 22.2600 | In distribution | |
| gS 22.9180 | In distribution | |
| gS 22.7708 | In distribution | |
| gS 22.1820 | In distribution | |
| gS 22.2780 | In distribution | |
| gS 22.2880 | In distribution | |
| gS 22.8460 | In distribution | |
| gS 22.2560 | In distribution | |
| gS 22.2590 | In distribution | |
| gS 17.0930 | In distribution | |
| gS 22.2860 | In distribution | |
| gS 22.2820 | In distribution | |
| gS 22.2660 | In distribution | |
| gS 22.2656 | In distribution | |
| gS 22.1780 | In distribution | |
| gS 22.9260 | In distribution | |
| FH.22.2660 | In distribution | |
| gS 22.8470 | In distribution | |
| FH.22.2780 | In distribution | |
| FH.22.4080 | In distribution | |
| gS 22.7704 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Delacroix-Chevalier | Landanger | 1,819 |
| Landanger | Landanger | 1,213 |
| Ambler Surgical | Ambler Surgical, LLC | 1,013 |
| Pilling | Teleflex Medical LLC | 971 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 876 |
| V. Mueller | Steris Corporation | 716 |
| Novo Surgical | Novo Surgical, Inc. | 387 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 364 |
| Instruments, Surgical, Cardiovascular | Fehling Instruments GmbH | 352 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 290 |
| Avalign | Avalign Technologies, Inc. | 283 |
| Millennium | Avalign Technologies, Inc. | 272 |
Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular
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.