Block high CF ExaFix™ CFBH
Block high CF ExaFix™ CFBH (110520) is a Class II device made by Macromedics B.V., cleared under FDA 510(k) K142420 on 27 Mar 2015 and listed in FDA GUDID since 31 Dec 2016 (UDI-DI 08719425700915), active as of 23 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 | Number08719425700915 | Date31 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142420 | Date27 Mar 2015 | StatusActive |
Official records
- AccessGUDID record 08719425700915
- FDA 510(k) database K142420
Across registries
- FDA 510(k) K142420 decided 27 Mar 2015 Active
- FDA GUDID UDI-DI 08719425700915 listed 31 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K142420
- Listed FDA GUDID 08719425700915
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Block high CF ExaFix™
- Generic name
- Indexed-immobilization patient positioning system
- Model / Ref / Catalog
- CFBH, 110520
- Primary DI / UDI-DI
- 08719425700915
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Indexed-immobilization patient positioning system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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