Avalign
Heany Uterine Curette serrated edges, loop width 7.5mm OL 245mm(9 5/8")
8manufacturers in China registered for this device type
16catalogue 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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | HCY |
| Device type | Curette, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM57-6357 | In distribution | |
| VM57-4242 | In distribution | |
| VM57-4213 | In distribution | |
| VM57-6381 | In distribution | |
| VM57-4217 | In distribution | |
| VM57-4215 | In distribution | |
| VM57-6356 | In distribution | |
| VM57-6395 | In distribution | |
| VM57-4233 | In distribution | |
| VM57-3053 | In distribution | |
| VM57-4219 | In distribution | |
| VM57-4225 | In distribution | |
| VM57-3001 | In distribution | |
| VM57-4223 | In distribution | |
| VM57-3051 | In distribution | |
| VM57-4221 | 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.