Product code EZP
- Device name
- Rod, Colostomy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4270
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00661613006164 | Loop Ostomy Rod | Marlen Manufacturing And Development Co. | 2026-05-03 |
| 00661613006171 | Loop Ostomy Rod | Marlen Manufacturing And Development Co. | 2026-05-03 |
| 00661613006188 | Loop Ostomy Rod | Marlen Manufacturing And Development Co. | 2026-05-03 |
| 00661613006195 | Loop Ostomy Rod | Marlen Manufacturing And Development Co. | 2026-05-03 |
| 00661613006201 | Loop Ostomy Rod | Marlen Manufacturing And Development Co. | 2026-05-03 |
| 00860002701356 | Barbell Loop Ostomy Device | TOOLS FOR SURGERY, LLC | 2023-07-17 |
| 00860002701349 | Barbell Loop Ostomy Device | TOOLS FOR SURGERY, LLC | 2023-07-17 |
| 00860002701325 | Barbell Loop Ostomy Device | TOOLS FOR SURGERY, LLC | 2023-07-17 |
| 05708932752558 | Coloplast | Coloplast A/S | 2022-12-26 |
| 00768455116003 | NATURA | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 10768455116000 | NATURA | CONVATEC, PURCHASING DEPARTMENT | 2022-09-28 |
| 00768455116010 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2019-03-22 |
| 10768455116017 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2019-03-22 |
| 00610075077670 | Hollister | HOLLISTER INCORPORATED | 2016-09-21 |
| 20610075077674 | Hollister | HOLLISTER INCORPORATED | 2016-09-21 |
| 20610075114058 | New Image | HOLLISTER INCORPORATED | 2016-09-21 |
| 20610075114089 | New Image | HOLLISTER INCORPORATED | 2016-09-21 |
| 20610075114119 | New Image | HOLLISTER INCORPORATED | 2016-09-21 |
| 20610075114140 | New Image | HOLLISTER INCORPORATED | 2016-09-21 |
| 00768455115501 | SUR-FIT LOOP OSTOMY ROD 65MM | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |
| 00768455115983 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |
| 00768455115990 | SUR-FIT NATURA | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |
| 10768455115508 | SUR-FIT LOOP OSTOMY ROD 65MM | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |
| 00768455115518 | SUR-FIT LOOP OSTOMY ROD 90MM | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |