Gynex
31 catalogue numbers from CBU3920-3, listed by Gynex Corporation, United States, under Curette, Uterine. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| 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 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Anhui Dajiang Medical Products Co., Ltd. | Chuzhou | Anhui | Manufacturer | 12 |
| Zhangzhou Aoxi Plastic Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 7 |
Record
| Listed by | Gynex Corporation, United States |
|---|---|
| FDA product code | HCY |
| Device type | Curette, 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 |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CBU3920-3 | In distribution | |
| TB3040 | In distribution | |
| 3015 | In distribution | |
| CSU3900-4 | In distribution | |
| 3302 | In distribution | |
| 3020 | In distribution | |
| TC3015 | In distribution | |
| CSU3900-5 | In distribution | |
| TC3020 | In distribution | |
| CSU3900-9 | In distribution | |
| 3310 | In distribution | |
| TC3010 | In distribution | |
| 3005 | In distribution | |
| 3314 | In distribution | |
| CBU3920-2 | In distribution | |
| CBU3920-1 | In distribution | |
| 3025 | In distribution | |
| 3304 | In distribution | |
| TC3040 | In distribution | |
| 3312 | In distribution | |
| CSU3900-1 | In distribution | |
| CSU3900-6 | In distribution | |
| 3040 | In distribution | |
| 3010 | In distribution | |
| CSU3900-3 | In distribution | |
| 3303 | In distribution | |
| CSU3900-0 | In distribution | |
| 3050 | In distribution | |
| TC3005 | In distribution | |
| TC3025 | In distribution | |
| CSU3900-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,021 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 118 |
| Aesculap | Aesculap AG | 105 |
| Sklar® | Sklar Corporation | 85 |
| Millennium | Avalign Technologies, Inc. | 78 |
| Hayden Medical | Hayden Medical Inc | 68 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 67 |
| Novo Surgical | Novo Surgical, Inc. | 50 |
| Ambler Surgical | Ambler Surgical, LLC | 37 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| V. Mueller | Steris Corporation | 34 |
| MedGyn Uterine Curette | Medgyn Products, Inc. | 33 |
Showing 12 of 59. All products under Curette, 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.