Motor, Surgical Instrument, Pneumatic Powered
Repeat Sternotomy SAW
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Shanghai Foreign Trade Enterprises Pudong Co., Ltd. | Shanghai | Shanghai | Exporter | 12 |
| Wenzhou Ezekiel Creative Electronic Technology Co., Ltd. | Wenzhou | Zhejiang | Repacker / relabeller | 4 |
| Wenzhou Songling Healthcare Equipment Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 4 |
| Shanghai Bojin Electric Instrument & Device Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Ningbo Boly Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Repacker / relabeller | 2 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | GET |
| Device type | Motor, Surgical Instrument, Pneumatic Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-11-28 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2022-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5057-040 | In distribution | |
| 1207-202 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 268 |
| Leopard | Imedicom Co., Ltd. | 15 |
| Ultrapower | ConMed Corporation | 14 |
| Conmed | ConMed Corporation | 7 |
| Leopard Micro | Imedicom Co., Ltd. | 6 |
| MicroAire® | Microaire Surgical Instruments LLC | 5 |
| Aesculap | Aesculap AG | 5 |
| HI-Line XS | Aesculap AG | 5 |
| Hall Osteon | ConMed Corporation | 4 |
| HI-Line | Aesculap AG | 3 |
| Endo Dissect | Covidien LP | 3 |
| The Woodpecker | IMT Integral Medizintechnik AG | 1 |
Showing 12 of 22. All products under Motor, Surgical Instrument, Pneumatic 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.