Mallet
Vickers, 300 Grams, W/Interchangeable Faces, 25 MM Diameter Head
3manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | GFJ |
| Device type | Mallet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2024-08-27 (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 |
|---|---|---|
| 01-002-85-07 | 14 CM | In distribution |
| 23-238-26-04 | 26 CM | In distribution |
| 48-727-20-07 | 21 CM | In distribution |
| 23-216-01-07 | 16.5 CM | In distribution |
| 23-204-02-07 | 21 CM | In distribution |
| 23-260-02-07 | 26 CM | In distribution |
| 23-264-19-04 | 19 CM | In distribution |
| 23-208-20-07 | 20 CM | In distribution |
| 23-226-18-07 | 18 CM | In distribution |
| 23-224-18-07 | 19 CM | In distribution |
| 23-204-01-07 | 19 CM | In distribution |
| 23-214-02-07 | 19 CM | In distribution |
| 23-204-03-07 | 20 CM | In distribution |
| 01-002-86-07 | 19 CM | In distribution |
| 23-262-19-04 | 18 CM | In distribution |
| 23-220-17-02 | 19 CM | In distribution |
| 23-214-01-07 | 19 CM | In distribution |
| 23-260-01-07 | 26.5 CM | Withdrawn |
| 23-215-19-07 | 19 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 86 |
| Millennium | Avalign Technologies, Inc. | 67 |
| gSource | Gsource, LLC. | 62 |
| Boss Instruments | Boss Instruments, Ltd. | 43 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Surtex | Surtex Instruments Ltd | 36 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 30 |
| Orthomed | Ortho-MED, Inc. | 28 |
| HNM Medical | HNM Stainless, LLC. | 26 |
| Kmedic | Teleflex Medical LLC | 23 |
| Avalign | Avalign Technologies, Inc. | 23 |
| V. Mueller | Steris Corporation | 22 |
Showing 12 of 91. All products under Mallet, Surgical, General & Plastic Surgery
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.