Aesculap
Sternum SAW Bl.rapid ACT.35/75/0.7/0.9MM
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | DWH |
| Device type | Blade, Saw, Surgical, Cardiovascular |
| 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 | 2020-05-08 |
| Record revised | 2022-08-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GC761R | In distribution | |
| GC681R | In distribution | |
| GC675R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blade, Saw, Surgical, Cardiovascular | Stryker GmbH | 12 |
| Symmetry Ultra™ Reveal | Aspen Surgical Products, Inc. | 11 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 7 |
| Traus | Saeshin Precision Co., Ltd. | 5 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Stryker Performance Series | Stryker GmbH | 2 |
| Symmetry Jacobson | Aspen Surgical Products, Inc. | 1 |
| Symmetry Scoville | Aspen Surgical Products, Inc. | 1 |
| Symmetry Taylor | Aspen Surgical Products, Inc. | 1 |
| Symmetry Scoville-Meyerding | Aspen Surgical Products, Inc. | 1 |
| Symmetry Wolff-Boehler | Aspen Surgical Products, Inc. | 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.