ColActive® Plus 4x4 5550440
ColActive® Plus 4x4 5550440 is a device classified as Unclassified made by Covalontechnologies, Inc., cleared under FDA 510(k) K060804 on 18 Apr 2006 and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 00825439011218), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00825439011218 | Date30 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060804 | Date18 Apr 2006 | StatusActive |
Official records
- AccessGUDID record 00825439011218
- FDA 510(k) database K060804
Across registries
- FDA 510(k) K060804 decided 18 Apr 2006 Active
- FDA GUDID UDI-DI 00825439011218 listed 30 Nov 2022 Listed
Recalls
-
- Ongoing Z-1796-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Timeline
- Cleared FDA 510(k) K060804
- Recall initiated FDA recalls Z-1796-2022
- Listed FDA GUDID 00825439011218
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ColActive® Plus 4"x4"
- Generic name
- Animal-derived wound matrix dressing
- Model / reference
- 5550440
- Primary DI / UDI-DI
- 00825439011218
- FDA product code
- FRO
- GMDN term
- Animal-derived wound matrix dressing
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 4 InchWidth — 4 Inch