VitriFreeze VF1001
by Fertipro NV
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
VitriFreeze Freezing 1 (REF: VF1001) is a cell culture media specifically designed for the vitrification of morula and blastocyst stage human embryos. This medium provides a physiological environment that supports the retrieval, culture, maintenance, transfer, and storage of these critical reproductive cells.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05411967002030 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070135 | Date16 Aug 2007 | StatusActive |
Official records
- AccessGUDID record 05411967002030
- FDA 510(k) database K070135
Across registries
- FDA 510(k) K070135 decided 16 Aug 2007 Active
- FDA GUDID UDI-DI 05411967002030 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K070135
- Listed FDA GUDID 05411967002030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VitriFreeze
- Generic name
- IVF medium
- Model / reference
- VF1001
- Primary DI / UDI-DI
- 05411967002030
- 510(k) Number
- FDA product code
- MQL
- GMDN term
- IVF medium
- Device class
- Class II
- Regulation number
- 884.6180
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 1 Milliliter
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