Helmut Zepf
Nipper, Malleus Cohen, Soft Tissue Nippers, 10 CM
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | JYR |
| Device type | Nipper, Malleus |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2023-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46.482.10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Princeton | Princeton Medical Group, Inc. | 15 |
| Marina Medical | Marina Medical Instruments, Inc. | 11 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 8 |
| Aesculap | Aesculap AG | 5 |
| Nipper | KLS-Martin L.P. | 5 |
| Millennium | Avalign Technologies, Inc. | 5 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 4 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Pilling | Teleflex Medical LLC | 3 |
| Ambler Surgical | Ambler Surgical, LLC | 3 |
| Dieter malleus nipper | Spiggle & Theis Medizintechnik Gmbh | 3 |
| BR Surgical, LLC | BR Surgical LLC | 2 |
Showing 12 of 26. All products under Nipper, Malleus
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.