Gynex
13 catalogue numbers from 1326, listed by Gynex Corporation, United States, under Punch, Biopsy, Surgical. 1 manufacturer in China is registered for this product code.
1manufacturer
13catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Gynex Corporation, United States |
|---|---|
| FDA product code | EME |
| Device type | Punch, Biopsy, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-06-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1326 | 25 | In distribution | |
| 1324 | 25 | In distribution | |
| 1305 | In distribution | ||
| 1303 | In distribution | ||
| 1307 | In distribution | ||
| 1304 | In distribution | ||
| 1310 | 6 | In distribution | |
| 1322 | 25 | In distribution | |
| 1302 | In distribution | ||
| 1306 | In distribution | ||
| 1328 | 25 | In distribution | |
| 1325 | 25 | In distribution | |
| 1323 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 36 |
| Sklar Instruments | Sklar Corporation | 24 |
| Kohdent | Kohler Medizintechnik GmbH | 22 |
| Osung MND | Osung MND Co., Ltd. | 20 |
| Medline | Medline Industries, Inc. | 20 |
| Acu-Punch | Acuderm, Inc. | 17 |
| Exel Biopsy Punch | Exel Inc. | 11 |
| Shard | Applied Dental, Inc. | 9 |
| Biotanium | Basic Dental Implant Systems, Inc. | 7 |
| Punches, Nobel | Omnia Medical | 6 |
| Salvin Stainless Steel Multi-Use Rotary Tissue Punch – 4mm | Salvin Dental Specialties, LLC | 5 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 4 |
Showing 12 of 64. All products under Punch, Biopsy, Surgical
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.