Boss Instruments
Bone Mallet, 1 3/4" ss head, 10 3/4", 2 lbs. head weight, 3.25 lbs. total weight
3manufacturers in China registered for this device type
43catalogue 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 | Boss Instruments, Ltd., United States |
|---|---|
| FDA product code | GFJ |
| Device type | Mallet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
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 |
|---|---|---|
| 93-0203 | In distribution | |
| 93-0234 | In distribution | |
| 93-0236 | In distribution | |
| 77-1120 | In distribution | |
| 93-0226 | In distribution | |
| 93-0222 | In distribution | |
| 77-1102 | In distribution | |
| 93-0220 | In distribution | |
| 93-0230 | In distribution | |
| 93-0206 | In distribution | |
| 93-0235 | In distribution | |
| 93-0205 | In distribution | |
| 93-0212 | In distribution | |
| 77-1093 | In distribution | |
| 93-0218 | In distribution | |
| 93-0209 | In distribution | |
| 93-0221 | In distribution | |
| 593-0227 | In distribution | |
| 93-0200 | In distribution | |
| 77-1100 | In distribution | |
| 93-0208 | In distribution | |
| 93-0217 | In distribution | |
| 93-0201 | In distribution | |
| 93-0227 | In distribution | |
| 93-0215 | In distribution | |
| 93-0239 | In distribution | |
| 93-0207 | In distribution | |
| 593-0228 | In distribution | |
| 93-0238 | In distribution | |
| 93-0237 | In distribution | |
| 93-0224 | In distribution | |
| 93-0213 | In distribution | |
| 93-0233 | In distribution | |
| 93-0232 | In distribution | |
| 93-0211 | In distribution | |
| 93-0216 | In distribution | |
| 93-0228 | In distribution | |
| 93-0225 | In distribution | |
| 77-1091 | In distribution | |
| 96-5610 | In distribution | |
| 93-0210 | In distribution | |
| 93-0223 | In distribution | |
| 93-0204 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 86 |
| Millennium | Avalign Technologies, Inc. | 67 |
| gSource | Gsource, LLC. | 62 |
| 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 |
| 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.