Duns Number:229044524
Catalog Number
-
Brand Name
Medium 199, Earle's Salts
Version/Model Number
31150022
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 12, 2022
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
KIT
Product Code Name
MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE
Public Device Record Key
e2574cb1-c7ca-4b45-a7ae-8e13481b1b04
Public Version Date
April 21, 2022
Public Version Number
5
DI Record Publish Date
August 04, 2016
Package DI Number
30190302004064
Quantity per Package
10
Contains DI Package
10190302004060
Package Discontinue Date
April 12, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 26 |