Wound Crown
Catalogue number 00860013000301, listed by Fistula Solution Corporation, United States, under Appliance, Colostomy, Disposable. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Hubei Hendry Medical Appliance Co., Ltd. | Xiaogan | Hubei | Manufacturer | 12 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Ningbo Kehu Medical Technology Co., Ltd. | Ningbo | Zhejiang | Specification developer | 7 |
Record
| Listed by | Fistula Solution Corporation, United States |
|---|---|
| FDA product code | EZS |
| Device type | Appliance, Colostomy, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-20 |
| Record revised | 2023-12-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00860013000301 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Safe N Simple | Safe N Simple LLC | 153 |
| Halyard | O&M Halyard, Inc. | 12 |
| Vitus | HR Pharmaceuticals Inc. | 11 |
| SUR-FIT Natura | Convatec, Purchasing Department | 8 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
| Natura | Convatec, Purchasing Department | 2 |
| SUR-FIT | Convatec, Purchasing Department | 2 |
| Ostoh | Ostoh, LLC | 1 |
| Isolator Strip | Fistula Solution Corporation | 1 |
| UltraMax | Marlen Manufacturing And Development Co. | 1 |
| Fistula Funnel | Fistula Solution Corporation | 1 |
| Carbou | Ningbo Kehu Medical Technology Co., Ltd. | 1 |
Showing 12 of 15. All products under Appliance, Colostomy, Disposable
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.