Avalign
Bergman Hibbs Mallet OL 255mm (10")
3manufacturers in China registered for this device type
23catalogue 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 | Avalign Technologies, Inc., 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 | 2021-11-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM104-1316 | In distribution | |
| VM104-1345 | In distribution | |
| VM104-1324 | In distribution | |
| VM104-1339 | In distribution | |
| VM104-1318 | In distribution | |
| VM88-2101 | In distribution | |
| VM104-1310 | In distribution | |
| VM104-1321 | In distribution | |
| VM88-2102 | In distribution | |
| VM104-1317 | In distribution | |
| VM104-1348 | In distribution | |
| VM104-1411 | In distribution | |
| VM104-1333 | In distribution | |
| VM104-1314 | In distribution | |
| VM104-1315 | In distribution | |
| VM104-1338 | In distribution | |
| VM104-1332 | In distribution | |
| VM104-1326 | In distribution | |
| VM104-1331 | In distribution | |
| VM104-1312 | In distribution | |
| VM88-2104 | In distribution | |
| VM104-1311 | In distribution | |
| VM104-1349 | In distribution |
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 |
| V. Mueller | Steris Corporation | 22 |
| Mallet | KLS-Martin L.P. | 19 |
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.