Amnicot
2 catalogue numbers from Amnicot English, listed by GO Medical Industries PTY. Ltd., Australia, under Amniotome. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Zhangzhou Aoxi Plastic Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 7 |
Record
| Listed by | GO Medical Industries PTY. Ltd., Australia |
|---|---|
| FDA product code | HGE |
| Device type | Amniotome |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K850758 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Outer carton of 5200, second inner carton of 2600, inner carton of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Amnicot English | In distribution | |
| Amnicot German | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 2 |
| Arom-COT | Utah Medical Products, Inc. | 2 |
| MedGyn Disposable Amnio Hook | Medgyn Products, Inc. | 1 |
| mityhook | Coopersurgical, Inc. | 1 |
| Quinelato | Schobell Industrial Ltda | 1 |
| Amnihook Amniotic Membrane Perforator | Aspen Surgical Products, Inc. | 1 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 1 |
| Gimmi | Gimmi Gmbh | 1 |
| Aesculap | Aesculap AG | 1 |
| Mabis DMI | D-M-S Holdings, Inc. | 1 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 1 |
| ObstiHook | Cook Incorporated | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850758 | 1985-04-15 |
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.