BleedArrest ER 9110264
BleedArrest ER 9110264 is a device classified as Unclassified made by Hemostasis, LLC, cleared under FDA 510(k) K102459 on 3 Dec 2010 and listed in FDA GUDID since 20 Feb 2020 (UDI-DI 00858439001460), 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 | Number00858439001460 | Date20 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102459 | Date3 Dec 2010 | StatusActive |
Official records
- AccessGUDID record 00858439001460
- FDA 510(k) database K102459
Across registries
- FDA 510(k) K102459 decided 3 Dec 2010 Active
- FDA GUDID UDI-DI 00858439001460 listed 20 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K102459
- Listed FDA GUDID 00858439001460
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BleedArrest ER
- Generic name
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
- Model / reference
- 9110264
- Primary DI / UDI-DI
- 00858439001460
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 1.3 CentimeterLength — 3.8 Centimeter
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