Epoflier
EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Sapi MED SPA |
|---|---|
| FDA product code | FER |
| Device type | Anoscope And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K070913 |
| Record published | 2023-07-27 |
| Record revised | 2023-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Surgical retractor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 39 |
| ESI | FTT Medical, Inc. | 30 |
| THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 18 |
| Pak-its® | Derma Sciences Canada, Inc. | 7 |
| Petrolatum Gauze® | Derma Sciences Canada, Inc. | 7 |
| V. Mueller | Steris Corporation | 6 |
| GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 5 |
| Self-light anoscopes | Sapi MED SPA | 5 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Retractor | Sapi MED SPA | 4 |
| Anoscope | Sapi MED SPA | 4 |
| McKesson | Mckesson Medical-Surgical Inc. | 4 |
Showing 12 of 23. All products under Anoscope And Accessories
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.