Osseous Stapes Prosthesis Crimping Forceps
It is used to crimping of stapes piston loop after proper placement of stapes piston on long process of incus.
5manufacturers in China registered for this device type
1catalogue number
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 | EON Meditech PVT. Ltd., India |
|---|---|
| FDA product code | KAE |
| Device type | Forceps, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-07-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Laminated box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EI04 | 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.