Aesculap
Mallet, 9" (230 mm), diam. 11,50 mm, 20 mm, peek handle, stainless steel, 432 g, 180 g
3manufacturers in China registered for this device type
6catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | GFJ |
| Device type | Mallet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-06 |
| Record revised | 2025-03-04 (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 |
| Distribution end date | 2025-02-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MB303R | In distribution | |
| MB629R | In distribution | |
| MA239R | In distribution | |
| US142 | In distribution | |
| FL072K | In distribution | |
| MG704R | Withdrawn |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.