Helmut Zepf
Scissor, Surgical Tissue, Dental Goldman-Fox,gingivectomy Scissors, Straight, 13CM, Supercut, Onyx-Coating
6manufacturers in China registered for this device type
63catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EGN |
| Device type | Scissors, Surgical Tissue, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| 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 |
|---|---|---|
| 46.051.11TC | In distribution | |
| 46.200.13TISC | In distribution | |
| 46.640.09 | In distribution | |
| 46.207.13 | In distribution | |
| 46.057.11SC | In distribution | |
| 46.319.17TISC | In distribution | |
| 46.402.14 | In distribution | |
| 46.057.11TISC | In distribution | |
| 46.200.13TC | In distribution | |
| 46.111.16SC | In distribution | |
| 46.081.16TISC | In distribution | |
| 46.640.13 | In distribution | |
| 46.077.16TC | In distribution | |
| 46.516.14 | In distribution | |
| 46.404.14 | In distribution | |
| 46.123.17TISC | In distribution | |
| 46.077.16SC | In distribution | |
| 46.081.16 | In distribution | |
| 46.077.16TISC | In distribution | |
| 46.201.13 | In distribution | |
| 46.051.11TISC | In distribution | |
| 46.069.11 | In distribution | |
| 46.050.11 | In distribution | |
| 46.644.16 | In distribution | |
| 46.200.13 | In distribution | |
| 46.050.11TC | In distribution | |
| 46.123.17TC | In distribution | |
| 46.220.12 | In distribution | |
| 46.123.17 | In distribution | |
| 46.201.13SC | In distribution | |
| 46.319.17N | In distribution | |
| 46.057.11 | In distribution | |
| 46.123.17SC | In distribution | |
| 46.404.13 | In distribution | |
| 46.221.12 | In distribution | |
| 46.644.14 | In distribution | |
| 46.201.13TISC | In distribution | |
| 46.050.11SC | In distribution | |
| 46.321.16 | In distribution | |
| 46.121.17 | In distribution | |
| 46.111.16 | In distribution | |
| 46.431.14 | In distribution | |
| 46.133.12 | In distribution | |
| 46.431.14SC | In distribution | |
| 46.201.13TC | In distribution | |
| 46.200.13SC | In distribution | |
| 46.803.13HMSC | In distribution | |
| 46.645.15 | In distribution | |
| 46.319.17 | In distribution | |
| 46.077.16 | In distribution | |
| 46.431.14TISC | In distribution | |
| 46.319.17HZU | In distribution | |
| 46.402.13 | In distribution | |
| 46.641.11 | In distribution | |
| 46.051.11 | In distribution | |
| 46.321.16TISC | In distribution | |
| 46.081.16SC | In distribution | |
| 46.051.11SC | In distribution | |
| 46.320.16 | In distribution | |
| 46.517.14 | In distribution | |
| 46.207.13-64021 | In distribution | |
| 46.050.11TISC | In distribution | |
| 46.207.13SC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 1,038 |
| Scissors, Surgical Tissue, Dental | George Tiemann & Co. | 386 |
| Melpex | Melpex Beauty Instruments | 179 |
| Zoll-Dental | Zoll-Dental | 109 |
| J & J Instruments | J & J Instruments, LLC | 105 |
| Stoma® | Storz AM Mark Gmbh | 67 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 66 |
| ACE | Ace Surgical Supply Co., Inc. | 66 |
| Kohdent | Kohler Medizintechnik GmbH | 62 |
| Pomee | Pomee Corporation | 57 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 41 |
| devemed | Devemed Gmbh | 40 |
Showing 12 of 194. All products under Scissors, Surgical Tissue, Dental
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.