Gsource
Bariatric Extra Long Kelly Sponge Forceps 12 1/2" cvd fenestrated serr
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | KAE |
| Device type | Forceps, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-12-03 |
| Record revised | 2022-08-10 (version 4) |
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 22.7604 | In distribution | |
| gS 20.8000 | In distribution | |
| gS 22.7602 | In distribution | |
| gS 22.7606 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 400 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 308 |
| Boss Instruments | Boss Instruments, Ltd. | 278 |
| Pilling | Teleflex Medical LLC | 252 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 234 |
| Aesculap | Aesculap AG | 229 |
| V. Mueller | Steris Corporation | 210 |
| BR Surgical, LLC | BR Surgical LLC | 195 |
| Millennium | Avalign Technologies, Inc. | 192 |
| Integra® | Integra LifeSciences Production Corporation | 191 |
| MicroFrance® | Integra Microfrance SAS | 183 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 180 |
Showing 12 of 318. All products under Forceps, Ent
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.