Aesculap
DESCHAMPS Ligature Needle for left hand, curved to right, 8 7/8", (225 mm), steep turn, blunt, non-sterile, reusable
3manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Anhui (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 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GDL |
| Device type | Needle, Suturing, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-17 |
| Record revised | 2023-08-22 (version 4) |
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 |
| Distribution end date | 2022-03-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BM810R | In distribution | ||
| BM711R | In distribution | ||
| BM802R | In distribution | ||
| BM856R | In distribution | ||
| BM825R | In distribution | ||
| BM728R | In distribution | ||
| BM749R | In distribution | ||
| BM809R | In distribution | ||
| BM770R | In distribution | ||
| BM823R | In distribution | ||
| BM713R | In distribution | ||
| BM812R | In distribution | ||
| BM858R | In distribution | ||
| BM780R | In distribution | ||
| BM712R | In distribution | ||
| BL301N | 12 | In distribution | |
| BM726R | In distribution | ||
| BM748R | In distribution | ||
| BM824R | In distribution | ||
| BM801R | In distribution | ||
| BM727R | In distribution | ||
| BM808R | In distribution | ||
| BM729R | In distribution | ||
| BM811R | In distribution | ||
| BM813R | In distribution | ||
| BM781R | In distribution | ||
| BM807R | In distribution | ||
| BM855R | In distribution | ||
| BM806R | In distribution | ||
| BM771R | In distribution | ||
| BL212N | 12 | In distribution | |
| BM714R | In distribution | ||
| BM822R | In distribution | ||
| BM814R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 22 |
| Ambler Surgical | Ambler Surgical, LLC | 21 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 20 |
| Stoma® | Storz AM Mark Gmbh | 16 |
| Millennium | Avalign Technologies, Inc. | 14 |
| Boss Instruments | Boss Instruments, Ltd. | 14 |
| Novo Surgical | Novo Surgical, Inc. | 8 |
| Avalign | Avalign Technologies, Inc. | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
| Jedmed | Jedmed Instrument Company | 3 |
| BR Surgical, LLC | BR Surgical LLC | 2 |
| V. Mueller | Carefusion 2200, Inc. | 2 |
Showing 12 of 23. All products under Needle, Suturing, Reusable
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.