Duns Number:711091157
Device Description: Individual vial
Catalog Number
91081
Brand Name
ES(Equilibration Solution)
Version/Model Number
VT601US-ES
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"
Yes
For Single-Use
Yes
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
867d3375-e4da-49fd-bf1c-4c64bc3f43be
Public Version Date
February 26, 2020
Public Version Number
1
DI Record Publish Date
February 18, 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. | 177 |