Soft-ECC
Endocervical curette system for tissue collection, storage, and transport.
8manufacturers in China registered for this device type
1catalogue number
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 | Histologics LLC, United States |
|---|---|
| FDA product code | HCY |
| Device type | Curette, Uterine |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 250 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SFT-2000 | 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.