Motor, Surgical Instrument, Ac-Powered
MOTOR HANDPIECE MAX. 6000RPM connection cable 8564851 required, for use with rotation morcellators, control by footswitch, reusable
7manufacturers in China registered for this device type
10catalogue 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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-27 |
| Record revised | 2025-12-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Ethylene Oxide, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
| Sizes | Outer diameter 4.5 to 5.5 mm; length 460 mm; length 3 m |
| Distribution end date | 2025-12-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8564121 | In distribution | ||
| 8564851 | Length 3 m | In distribution | |
| 163955 | In distribution | ||
| 163951 | In distribution | ||
| 163956 | In distribution | ||
| 8564122 | In distribution | ||
| 809510205 | Length 3 m | In distribution | |
| 4256305463US | Outer Diameter 5.5 mm | 3 | Withdrawn |
| 809510002 | Withdrawn | ||
| 4256204463US | Outer Diameter 4.5 mm | 3 | Withdrawn |
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.