Duns Number:373904101
Device Description: VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of VitriThaw™ Thawing 2 (REF: VT2001) (1 ml) Component of VitriThaw™ kit, which are a set of cell culture media designed for the thawing of vitrified morula and blastocyst stage human embryos (with VitriFreeze™ kit) .For more information, see DI Number of VitriThaw kit: 05411967001439. The medium has a 12 month shelf life.For the latest version of the instructions for use or MSDS, visit the product page on our website (www.fertipro.com).
Catalog Number
-
Brand Name
VitriThaw
Version/Model Number
VT2001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
ea51391b-4ab9-4e00-a4fa-5220bd060236
Public Version Date
September 17, 2020
Public Version Number
4
DI Record Publish Date
September 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |