Loop Ostomy Rod
3in long with eyelets at one end and T-Bar at other end
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | Marlen Manufacturing And Development Co. |
|---|---|
| FDA product code | EZP |
| Device type | Rod, Colostomy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4270 |
| Premarket notification | Exempt |
| Record published | 2026-05-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 620 | In distribution | |
| 617 | In distribution | |
| 618 | In distribution | |
| 619 | In distribution | |
| 616 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SUR-FIT Natura | Convatec, Purchasing Department | 3 |
| Barbell Loop Ostomy Device | Tools FOR Surgery, LLC | 3 |
| SUR-FIT Loop Ostomy ROD 65MM | Convatec, Purchasing Department | 1 |
| Hollister | Hollister Incorporated | 1 |
| SUR-FIT Loop Ostomy ROD 90MM | Convatec, Purchasing Department | 1 |
| Natura | Convatec, Purchasing Department | 1 |
| Coloplast | Coloplast A/S | 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.