Gynex
6 catalogue numbers from 4336, listed by Gynex Corporation, United States, under Sound, Uterine. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), 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 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Yangzhong Meidi Medical Products Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Gynex Corporation, United States |
|---|---|
| FDA product code | HHM |
| Device type | Sound, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4336 | In distribution | ||
| 4334 | In distribution | ||
| 4675 | 25 | In distribution | |
| 4630 | 25 | In distribution | |
| 4601 | 25 | In distribution | |
| 4950 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 104 |
| Gimmi | Gimmi Gmbh | 32 |
| HNM Medical | HNM Stainless, LLC. | 13 |
| Aesculap | Aesculap AG | 12 |
| Symmetry Sims | Aspen Surgical Products, Inc. | 9 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 7 |
| BR Surgical, LLC | BR Surgical LLC | 6 |
| GEN2 | Surgix Medical LLC | 6 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| V. Mueller | Steris Corporation | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 5 |
Showing 12 of 43. All products under Sound, Uterine
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.