Integra® Miltex®
Integra® Miltex® Beacham Amniotome, 10-1/4"
5manufacturers in China registered for this device type
1catalogue number
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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HGE |
| Device type | Amniotome |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2023-04-27 (version 3) |
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 |
|---|---|---|
| 30-2260 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amnicot | GO Medical Industries PTY. Ltd. | 2 |
| 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 |
| 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 |
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.