ACTICOAT Flex 66027683
by Smith & Nephew Medical, Ltd.
ACTICOAT Flex 66027683 is a device classified as Unclassified made by Smith & Nephew Medical, Ltd., cleared under FDA 510(k) K083113 on 22 Jul 2009 and listed in FDA GUDID since 26 Mar 2026 (UDI-DI 05000223503727), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05000223503727 | Date26 Mar 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083113 | Date22 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 05000223503727
- FDA 510(k) database K083113
Across registries
- FDA 510(k) K083113 decided 22 Jul 2009 Active
- FDA GUDID UDI-DI 05000223503727 listed 26 Mar 2026 Listed
Timeline
- Cleared FDA 510(k) K083113
- Listed FDA GUDID 05000223503727
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ACTICOAT Flex
- Generic name
- Wound-nonadherent dressing, absorbent, antimicrobial
- Model / Ref / Catalog
- 66027683
- Primary DI / UDI-DI
- 05000223503727
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Wound-nonadherent dressing, absorbent, antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Width — 1 InchLength — 24 Inch
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