Hemasorb Apply OSA-351
by Abyrx, Inc.
Hemasorb Apply OSA-351 is a device classified as Unclassified made by Abyrx, Inc., cleared under FDA 510(k) K102762 on 15 Feb 2011 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00850391007054), 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 | Number00850391007054 | Date3 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102762 | Date15 Feb 2011 | StatusActive |
Official records
- AccessGUDID record 00850391007054
- FDA 510(k) database K102762
Across registries
- FDA 510(k) K102762 decided 15 Feb 2011 Active
- FDA GUDID UDI-DI 00850391007054 listed 3 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K102762
- Listed FDA GUDID 00850391007054
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hemasorb Apply
- Generic name
- Bone wax, synthetic
- Model / reference
- OSA-351
- Primary DI / UDI-DI
- 00850391007054
- FDA product code
- MTJ
- GMDN term
- Bone wax, synthetic
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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