Kmedic
Ortho Mallet Lightweight 7" 1 Pound 2 OUNCE/8 Ounce
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 | Teleflex Medical LLC, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-10 (version 3) |
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, manufacturing date |
| Sizes | Length 2.5 to 27.9 cm; width 18 to 85 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN014865 | Width 19 mm | In distribution | |
| IPN013960 | Width 56 mm | In distribution | |
| IPN014869 | Width 20 mm | In distribution | |
| IPN013973 | Length 2.5 cm | In distribution | |
| IPN013976 | Length 27.9 cm | In distribution | |
| IPN014868 | Length 20.3 cm | In distribution | |
| IPN013972 | Length 19 cm | In distribution | |
| IPN013955 | Length 19.1 cm | In distribution | |
| IPN013959 | Width 36 mm | In distribution | |
| IPN013974 | Width 55 mm | In distribution | |
| IPN013958 | Length 20.3 cm | In distribution | |
| IPN015190 | Length 22.9 cm | In distribution | |
| IPN013975 | Length 3.2 cm | In distribution | |
| IPN013979 | Length 3 cm | In distribution | |
| IPN013977 | Width 76 mm | In distribution | |
| IPN013961 | Length 2.5 cm | 2 | In distribution |
| IPN013978 | Length 27.9 cm | In distribution | |
| IPN014867 | Length 17.8 cm | In distribution | |
| IPN014864 | Width 30 mm | In distribution | |
| IPN013954 | Length 19.7 cm | In distribution | |
| IPN013957 | Width 60 mm | In distribution | |
| IPN013962 | Width 58 mm | In distribution | |
| IPN014866 | Length 19.1 cm | 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 |
| 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.