Duns Number:057475246
Device Description: Blastocyst Thaw Media Kit
Catalog Number
90110
Brand Name
Blastocyst Thaw Media Kit
Version/Model Number
90110-6X10ML
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2021
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000309
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
d8aeb1b9-103c-4c76-a2a9-05b15e40a135
Public Version Date
June 09, 2021
Public Version Number
6
DI Record Publish Date
September 10, 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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |