SUR-FIT Natura
Post Op Kit Sterile: Natura® Two-Piece, Drainable, 2 1/4" (57Mm), Transparent, Standard, With Invisiclose® Tail Closure, with Stomahesive® Cut-To-Fit Skin Barrier
49manufacturers in China registered for this device type
60catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Jiangsu (9), Shanghai (7). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Zhejiang TOP-Medical Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 49. All 49 manufacturers in China registered for Bag, Drainage, With Adhesive, Ostomy
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | FON |
| Device type | Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2018-11-16 |
| Record revised | 2023-05-31 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 14, case of 6, case of 20, case of 3 |
| Distribution end date | 2023-05-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 401500 | 10 | In distribution | |
| 401504 | 10 | In distribution | |
| 401928 | 10 | In distribution | |
| 404027 | 20 | In distribution | |
| 401515 | 10 | In distribution | |
| 401502 | 10 | In distribution | |
| 401932 | 10 | In distribution | |
| 404026 | 20 | In distribution | |
| 401936 | 10 | In distribution | |
| 404028 | 20 | In distribution | |
| 401510 | 10 | In distribution | |
| 404033 | 20 | In distribution | |
| 404016 | 20 | In distribution | |
| 404030 | 20 | In distribution | |
| 401511 | 10 | In distribution | |
| 401935 | 10 | In distribution | |
| 401505 | 10 | In distribution | |
| 404029 | 20 | In distribution | |
| 401508 | 10 | In distribution | |
| 404017 | 20 | In distribution | |
| 401501 | 10 | In distribution | |
| 401514 | 10 | In distribution | |
| 404018 | 20 | In distribution | |
| 401934 | 10 | In distribution | |
| 401933 | 10 | In distribution | |
| 404014 | 20 | In distribution | |
| 404034 | 20 | In distribution | |
| 401513 | 10 | In distribution | |
| 404025 | 20 | In distribution | |
| 401506 | 10 | In distribution | |
| 401507 | 10 | In distribution | |
| 404031 | 20 | In distribution | |
| 401503 | 10 | In distribution | |
| 401927 | 10 | In distribution | |
| 404032 | 20 | In distribution | |
| 401509 | 10 | In distribution | |
| 401512 | 10 | In distribution | |
| 404015 | 20 | In distribution | |
| 416950 | 5 | Withdrawn | |
| 421043 | 5 | Withdrawn | |
| 421046 | 5 | Withdrawn | |
| 416945 | 5 | Withdrawn | |
| 421044 | 5 | Withdrawn | |
| 416953 | 5 | Withdrawn | |
| 416937 | 5 | Withdrawn | |
| 416940 | 5 | Withdrawn | |
| 416926 | 5 | Withdrawn | |
| 416954 | 5 | Withdrawn | |
| 421042 | 5 | Withdrawn | |
| 416924 | 5 | Withdrawn | |
| 421047 | 5 | Withdrawn | |
| 416948 | 5 | Withdrawn | |
| 416918 | 5 | Withdrawn | |
| 416917 | 5 | Withdrawn | |
| 416942 | 5 | Withdrawn | |
| 416946 | 5 | Withdrawn | |
| 421045 | 5 | Withdrawn | |
| 416934 | 5 | Withdrawn | |
| 416920 | 1.75 inch diameter | 5 | Withdrawn |
| 416938 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Esteem+ | Convatec, Purchasing Department | 92 |
| Natura | Convatec, Purchasing Department | 39 |
| Activelife | Convatec, Purchasing Department | 39 |
| Eakin | T.G. Eakin, Ltd. | 14 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 14 |
| AWI | Apex (Suzhou) Medical Products Company | 12 |
| Esteem Synergy | Convatec, Purchasing Department | 12 |
| Coloplast | Coloplast A/S | 8 |
| Carbou | Ningbo Kehu Medical Technology Co., Ltd. | 6 |
| ViveCare | Vive Health LLC | 6 |
| Perilav | Stiehl Tech | 5 |
| Osto System | Solomed S.A. DE C.V. | 4 |
Showing 12 of 24. All products under Bag, Drainage, With Adhesive, Ostomy
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Convatec Limited | UDI-DI | 2024-01-17 | Class II | Labeling Change Control | The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring. | 1,715 units |
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.