SUR-FIT Natura
SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 1 1/2"
4manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Henan Maidingkang Medical Technology Co., Ltd. | Changyuan | Henan | Repacker / relabeller | 7 |
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | EXH |
| Device type | Bag, Urinary, Ileostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2018-12-07 |
| Record revised | 2023-01-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 401552 | 10 | In distribution | |
| 401550 | 10 | In distribution | |
| 401534 | 10 | In distribution | |
| 401555 | 10 | In distribution | |
| 401536 | 10 | In distribution | |
| 401542 | 10 | In distribution | |
| 401546 | 10 | In distribution | |
| 401551 | 10 | In distribution | |
| 401554 | 10 | In distribution | |
| 401553 | 10 | In distribution | |
| 401535 | 10 | In distribution | |
| 401540 | 10 | In distribution | |
| 401541 | 10 | In distribution | |
| 401548 | 10 | In distribution | |
| 401539 | 10 | In distribution | |
| 401537 | 10 | In distribution | |
| 401545 | 10 | In distribution | |
| 401538 | 10 | In distribution | |
| 401547 | 10 | In distribution | |
| 401544 | 10 | In distribution | |
| 401549 | 10 | In distribution | |
| 401543 | 10 | In distribution | |
| 401929 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Esteem | Convatec, Purchasing Department | 31 |
| Activelife | Convatec, Purchasing Department | 25 |
| MDK-Medical | Henan Maidingkang Medical Technology Co., Ltd. | 10 |
| Esteem Synergy | Convatec, Purchasing Department | 8 |
| Natura+ | Convatec, Purchasing Department | 5 |
| Bag, Urinary, Ileostomy | Henan Maidingkang Medical Technology Co., Ltd. | 2 |
| Accuseal | Convatec, Purchasing Department | 2 |
| Active Life | Convatec, Purchasing Department | 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.