V. Mueller
V. Mueller NO 3 KNIFE HANDLE FOR BLADES 10, 11, 12 and 15 ENGRAVED METRIC SCALE OVERALL LENGTH 5 inches 12.7CM
29manufacturers in China registered for this device type
31catalogue numbers in this listing
1recall
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 | Steris Corporation, United States |
|---|---|
| FDA product code | GDZ |
| Device type | Handle, Scalpel |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2024-09-13 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SU1409 | In distribution | |
| OP1320 | In distribution | |
| SA1403-001 | In distribution | |
| SA1403-003 | In distribution | |
| SA1407 | In distribution | |
| OS01360 | In distribution | |
| SU1403-003 | In distribution | |
| OS0306 | In distribution | |
| SU1404-001 | In distribution | |
| OP1312 | In distribution | |
| OP0701 | In distribution | |
| OP0702 | In distribution | |
| OS01410 | In distribution | |
| H-0623 | In distribution | |
| CH0705 | In distribution | |
| SU01571 | In distribution | |
| NL3785-130 | In distribution | |
| OS01350 | In distribution | |
| SU1403-002 | In distribution | |
| OS01394 | In distribution | |
| SU1404-002 | In distribution | |
| SU1403-012 | In distribution | |
| SU1403-001 | In distribution | |
| SA1403-002 | In distribution | |
| SA1409 | In distribution | |
| SA1404-001 | In distribution | |
| OP0705 | In distribution | |
| SU1403-014 | In distribution | |
| OP0703 | In distribution | |
| OP0702-001 | In distribution | |
| SU1407 | In distribution |
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 |
| gSource | Gsource, LLC. | 29 |
| Handle | KLS-Martin L.P. | 28 |
| Sklar® | Sklar Corporation | 28 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 27 |
Showing 12 of 226. All products under Handle, Scalpel
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-09-02 | Class II | Process design | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient’s mouth which may result in a cut to the patient’s mouth and also presents a choking hazard. | 5 US; 62 OUS | 2025-01-02 |
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.