SUR-FIT Natura
SUR-FIT Natura® Disposable Convex Inserts, 1 5/8" Inner Diameter, Flange Size 2 1/4"
8manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Convatec, Purchasing Department |
|---|---|
| FDA product code | EZS |
| Device type | Appliance, Colostomy, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2022-09-28 |
| Record revised | 2022-10-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12, pack of 240, case of 20, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 404013 | 5 | In distribution | |
| 401909 | 25 | In distribution | |
| 404006 | 5 | In distribution | |
| 404011 | 5 | In distribution | |
| 404008 | 5 | In distribution | |
| 404012 | 5 | In distribution | |
| 404010 | 5 | In distribution | |
| 404009 | 5 | 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
| Natura | Convatec, Purchasing Department | 2 |
| SUR-FIT | Convatec, Purchasing Department | 2 |
| Ostoh | Ostoh, LLC | 1 |
| Wound Crown | Fistula Solution Corporation | 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.