Stryker
Penfield Reverse 4mm, Bayoneted
7manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | GEG |
| Device type | Elevator, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-15 |
| Record revised | 2024-01-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48970007 | In distribution | |
| 48970058 | In distribution | |
| 48970002 | In distribution | |
| 48970059 | In distribution | |
| 48970003 | In distribution | |
| 48970006 | In distribution | |
| 48970004 | In distribution | |
| 48970003S | Withdrawn | |
| 48970007S | Withdrawn | |
| 48970006S | Withdrawn | |
| 48970004S | Withdrawn | |
| 48970002S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 531 |
| Zoll-Dental | Zoll-Dental | 415 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 262 |
| Millennium | Avalign Technologies, Inc. | 254 |
| Surtex | Surtex Instruments Ltd | 243 |
| Sklar | Sklar Corporation | 230 |
| gSource | Gsource, LLC. | 190 |
| Boss Instruments | Boss Instruments, Ltd. | 156 |
| Aesculap | Aesculap AG | 131 |
| Elevator | KLS-Martin L.P. | 119 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 104 |
| Hayden Medical | Hayden Medical Inc | 103 |
Showing 12 of 173. All products under Elevator, Surgical, General & Plastic Surgery
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.