Oscillating Microsaw G2
Catalogue number 1600657, listed by Bien-AIR Surgery SA, Switzerland, under Saw, Electrically Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guizhou (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
| Wuhu Ruijin Medical Instrument & Device Co., Ltd. | Wuhu | Anhui | Manufacturer | 1 |
Record
| Listed by | Bien-AIR Surgery SA, Switzerland |
|---|---|
| FDA product code | DWI |
| Device type | Saw, Electrically Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-07-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-07-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1600657 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseoscalpel Microsaw G2 | Bien-AIR Surgery SA | 1 |
| LapiLock | Fusion Orthopedics, LLC | 1 |
| Compass Microsaw G2 | Bien-AIR Surgery SA | 1 |
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.