Kincise™
Kincise FEM Head Impactor, Replace CAP
7manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Shenzhen Jinlichang Electronic Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-28 |
| Record revised | 2024-09-19 (version 7) |
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, serial number |
| Storage | Handling environment atmospheric pressure 59.5 to 106 KiloPascal; Handling environment temperature -29 to 60 °C; Handling environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000-00-101 | In distribution | |
| 1010-01-102 | In distribution | |
| 1011-01-101 | In distribution | |
| 1012-01-101 | In distribution | |
| 1010-01-101 | In distribution | |
| 1002-00-102 | In distribution | |
| 1013-00-901 | In distribution | |
| 1003-00-101 | In distribution | |
| 1013-00-101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 1,481 |
| HI-Line XS | Aesculap AG | 169 |
| Zaguar | Imedicom Co., Ltd. | 131 |
| Elan 4 | Aesculap AG | 107 |
| Aesculap | Aesculap AG | 72 |
| HI-Line | Aesculap AG | 53 |
| Motor, Surgical Instrument, Ac-Powered | Anspach Effort, The | 37 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 29 |
| Motor, Surgical Instrument, Ac-Powered | Synthes Gmbh | 29 |
| HI-Line XXS | Aesculap AG | 22 |
| Motor, Surgical Instrument, Ac-Powered | Smith & Nephew, Inc. | 20 |
| Eccos | Aesculap AG | 11 |
Showing 12 of 149. All products under Motor, Surgical Instrument, Ac-Powered
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.