Handle
Scalpel, Dura, Protective ARM, 7 MM Footplate
29manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (9), Zhejiang (3). 5 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 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Xiantao Sanda Industrial Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 10 |
| Ningbo Medsun Medical Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Scalpel
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | GDZ |
| Device type | Handle, Scalpel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2024-08-26 (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 | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-408-00-04 | 14 CM | In distribution |
| 10-159-00-09 | 13.5 CM | In distribution |
| 10-130-05-07 | 12 CM | In distribution |
| 99-595-03-01 | 15 CM | In distribution |
| 10-140-03-07 | 15.5 CM | In distribution |
| 10-133-35-07 | 20.5 CM | In distribution |
| 10-130-04-07 | 12 CM | In distribution |
| 99-594-61-01 | 17 CM | In distribution |
| 10-148-03-07 | 15 CM | In distribution |
| 10-133-31-07 | 21 CM | In distribution |
| 10-137-07-07 | 16 CM | In distribution |
| 10-104-45-07 | 21 CM | In distribution |
| 10-146-03-07 | 14.5 CM | In distribution |
| 10-100-04-07 | 13.5 CM | In distribution |
| 10-160-01-07 | 13.5 CM | In distribution |
| 10-120-04-07 | 16 CM | In distribution |
| 10-147-03-07 | 14.5 CM | In distribution |
| 10-137-71-07 | 13 CM | In distribution |
| 10-104-41-07 | 21 CM | In distribution |
| 10-130-03-07 | 12 CM | In distribution |
| 10-165-00-07 | 15 CM | In distribution |
| 99-595-03-02 | 15 CM | In distribution |
| 10-112-04-07 | 13.5 CM | Withdrawn |
| 10-109-09-07 | 14.5 CM | Withdrawn |
| 10-116-03-07 | Withdrawn | |
| 10-117-03-07 | Withdrawn | |
| 96-233-79-07 | 15 CM | Withdrawn |
| 10-118-03-07 | 15.5 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| comknife® | Beijing Bohai Kangyuan Medical Devices Co., Ltd. | 298 |
| Surgical Direct | Surgical Direct, Inc. | 68 |
| Millennium | Avalign Technologies, Inc. | 46 |
| Aesculap | Aesculap AG | 41 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 37 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 31 |
| V. Mueller | Steris Corporation | 31 |
| gSource | Gsource, LLC. | 29 |
| Sklar® | Sklar Corporation | 28 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 27 |
Showing 12 of 226. All products under Handle, Scalpel
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.