Gynex
10 catalogue numbers from 29-200, listed by Gynex Corporation, United States, under Remover, Intrauterine Device, Contraceptive, Hook-Type. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| 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 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
Record
| Listed by | Gynex Corporation, United States |
|---|---|
| FDA product code | HHF |
| Device type | Remover, Intrauterine Device, Contraceptive, Hook-Type |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-26 |
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 |
|---|---|---|---|
| 29-200 | 12 | In distribution | |
| 29-350 | In distribution | ||
| 29-300 | 12 | In distribution | |
| 29-850 | 2 | In distribution | |
| 29-800 | In distribution | ||
| 29020 | In distribution | ||
| 29-900 | In distribution | ||
| 29-550 | In distribution | ||
| 29010 | In distribution | ||
| 29-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HNM Medical | HNM Stainless, LLC. | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
| BR Surgical, LLC | BR Surgical LLC | 3 |
| Novo Surgical | Novo Surgical, Inc. | 3 |
| Hayden Medical | Hayden Medical Inc | 2 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 2 |
| Instrapac | Robinson Healthcare Limited | 2 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 2 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | Panpac Medical Corporation | 2 |
| Marina Medical | Marina Medical Instruments, Inc. | 2 |
| Pilling | Teleflex Medical LLC | 1 |
Showing 12 of 21. All products under Remover, Intrauterine Device, Contraceptive, Hook-Type
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.