Aesculap
Scalpel, 6 1/2", (165 mm), polymer handle, Fig. 67, stainless steel, yellow, sterile, disposable, package of 5 pieces
14manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 28 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
| Huaian Angel Medical Instrument Co., Ltd. | Huaian | Jiangsu | Manufacturer | 11 |
Showing 12 of 14. All 14 manufacturers in China registered for Scalpel, One-Piece
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GDX |
| Device type | Scalpel, One-Piece |
| 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 | 2020-04-24 |
| Record revised | 2022-02-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-10-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BA820SU | 10 | In distribution | |
| BA211 | 10 | In distribution | |
| BA215 | 10 | In distribution | |
| BA210 | 10 | In distribution | |
| BA221 | 10 | In distribution | |
| BA821SU | 10 | In distribution | |
| BA811SU | 10 | In distribution | |
| BA815-CSU | 10 | In distribution | |
| BA822SU | 10 | In distribution | |
| BA815-1SU | 10 | In distribution | |
| BA824SU | 10 | In distribution | |
| BA224 | 10 | In distribution | |
| BA815SU | 10 | In distribution | |
| BA222 | 10 | In distribution | |
| BA220 | 10 | In distribution | |
| BA219 | 10 | In distribution | |
| BA823SU | 10 | In distribution | |
| BA810SU | 10 | In distribution | |
| BA825SU | 10 | In distribution | |
| BA836SU | 10 | In distribution | |
| BA812SU | 10 | In distribution | |
| BA223 | 10 | In distribution | |
| BA819SU | 10 | In distribution | |
| BA818SU | 10 | In distribution | |
| BA212 | 10 | In distribution | |
| BA218 | 10 | In distribution | |
| BA364 | 5 | Withdrawn | |
| BA365 | 5 | Withdrawn | |
| BA367 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Swann Morton Ltd. | Swann Morton, Ltd. | 165 |
| Surgistar | Surgistar, Inc. | 142 |
| Bard-Parker ® Safety Scalped | Aspen Surgical Products, Inc. | 19 |
| McKesson | Mckesson Medical-Surgical Inc. | 15 |
| Kiato Plus | Aditya Dispomed Products Private Ltd. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 15 |
| Sandel | Ansell Sandel Medical Solutions LLC | 14 |
| Sklar® | Sklar Corporation | 14 |
| Feather Disposable Scalpel | Feather Safety Razor Co., Ltd. | 14 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 14 |
| Bard-Parker ® Disposable Scalpels | Aspen Surgical Products, Inc. | 13 |
| Lumohs | Nano Surgical, Inc | 12 |
Showing 12 of 56. All products under Scalpel, One-Piece
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.