BR Surgical, LLC
IUD Serpentine Grasper, flexible
6manufacturers in China registered for this device type
3catalogue 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 | BR Surgical LLC, United States |
|---|---|
| FDA product code | HHF |
| Device type | Remover, Intrauterine Device, Contraceptive, Hook-Type |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR70-63400 | In distribution | |
| BR70-63148 | In distribution | |
| BR70-63526 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gynex | Gynex Corporation | 10 |
| HNM Medical | HNM Stainless, LLC. | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 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.