ExSept Plus 100 mL
ExSept Plus 100 mL (15104) is a Class II device made by Angelini Pharma Inc., cleared under FDA 510(k) K082858 on 27 May 2009 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00898021000105), 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 | Number00898021000105 | Date29 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082858 | Date27 May 2009 | StatusActive |
Official records
- AccessGUDID record 00898021000105
- FDA 510(k) database K082858
Across registries
- FDA 510(k) K082858 decided 27 May 2009 Active
- FDA GUDID UDI-DI 00898021000105 listed 29 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K082858
- Listed FDA GUDID 00898021000105
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ExSept Plus
- Generic name
- Antimicrobial wound irrigation solution
- Model / Ref / Catalog
- 100 mL, 15104
- Primary DI / UDI-DI
- 00898021000105
- 510(k) Number
- FDA product code
- FQH
- GMDN term
- Antimicrobial wound irrigation solution
- Device class
- Class II
- Regulation number
- 880.5475
- GUDID distribution status
- In Commercial Distribution
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