Duns Number:544504573
Catalog Number
-
Brand Name
VitaVitro
Version/Model Number
Fertilization Medium, 60mL
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200408
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
2909f851-1017-452e-94fd-dfd3c1a3edfe
Public Version Date
November 06, 2020
Public Version Number
1
DI Record Publish Date
October 29, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 22 |