Product code FON
- Device name
- Bag, Drainage, With Adhesive, Ostomy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5900
- 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 |
|---|---|---|---|
| B674WIKE2001101 | Perilav | Stiehl Tech, LLC | 2026-05-13 |
| B674WIKE1401101 | Perilav | Stiehl Tech, LLC | 2026-05-13 |
| B674WIKB2001101 | Perilav | Stiehl Tech, LLC | 2026-05-13 |
| B674WIKB1402101 | Perilav | Stiehl Tech, LLC | 2026-05-13 |
| B674WIKB1401101 | Perilav | Stiehl Tech, LLC | 2026-05-13 |
| 16937359412394 | Maidwoc | Wuhan Sitaili Medical Apparatus Development Co., Ltd. | 2023-04-19 |
| 16937359412387 | Steawoce | Wuhan Sitaili Medical Apparatus Development Co., Ltd. | 2022-12-21 |
| 16937359412370 | Steawoce | Wuhan Sitaili Medical Apparatus Development Co., Ltd. | 2022-12-15 |
| 16937359412356 | Steadlive | Wuhan Sitaili Medical Apparatus Development Co., Ltd. | 2022-12-07 |
| 00762123051078 | Coloplast | Coloplast A/S | 2022-03-11 |
| 00762123049570 | Coloplast | Coloplast A/S | 2022-03-11 |
| 00762123049433 | Coloplast | Coloplast A/S | 2022-03-11 |
| 10080196998401 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-23 |
| 26972130470474 | AWI | Apex (Suzhou) Medical Products Company | 2020-12-04 |
| 26972130470467 | AWI | Apex (Suzhou) Medical Products Company | 2020-12-04 |
| 10080196990177 | Medline | MEDLINE INDUSTRIES, INC. | 2020-11-12 |
| 26972130470399 | AWI | Apex (Suzhou) Medical Products Company | 2020-10-27 |
| 26972130470382 | AWI | Apex (Suzhou) Medical Products Company | 2020-10-27 |
| 16972130470392 | AWI | Apex (Suzhou) Medical Products Company | 2020-10-27 |
| 16972130470385 | AWI | Apex (Suzhou) Medical Products Company | 2020-10-27 |
| 00040565111827 | Tincture of Benzoin Spray 4oz US | SMITH & NEPHEW MEDICAL LIMITED | 2020-09-04 |
| 00768455101481 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101474 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101467 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101450 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101443 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101436 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101429 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101412 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |
| 00768455101405 | ACTIVELIFE | CONVATEC, PURCHASING DEPARTMENT | 2018-11-09 |