CryoMini 4011
CryoMini 4011 is a Class II device made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K080735 on 4 Apr 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04053815003090), 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 | Number04053815003090 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080735 | Date4 Apr 2008 | StatusActive |
Official records
- AccessGUDID record 04053815003090
- FDA 510(k) database K080735
Across registries
- FDA 510(k) K080735 decided 4 Apr 2008 Active
- FDA GUDID UDI-DI 04053815003090 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K080735
- Listed FDA GUDID 04053815003090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CryoMini
- Generic name
- Localized cutaneous/musculoskeletal cryotherapy unit
- Model / Ref / Catalog
- 4011
- Primary DI / UDI-DI
- 04053815003090
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Localized cutaneous/musculoskeletal cryotherapy unit
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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