Barbell Loop Ostomy Device
Loop Ostomy Device, Medium (3-inch rod).
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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 | Tools FOR Surgery, LLC, United States |
|---|---|
| FDA product code | EZP |
| Device type | Rod, Colostomy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4270 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 2 to 4 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BAR-4 | Length 4 in | In distribution |
| BAR-2 | Length 2 in | In distribution |
| BAR-3 | Length 3 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Loop Ostomy Rod | Marlen Manufacturing And Development Co. | 5 |
| SUR-FIT Natura | Convatec, Purchasing Department | 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040110 | 2004-03-24 |
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.