Duns Number:118793157
Catalog Number
-
Brand Name
F-12 Nutrient Mix (Ham)
Version/Model Number
31765035
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 20, 2020
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
931311fe-653e-4b11-aa00-c84af6a1dc66
Public Version Date
March 05, 2021
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
30190302004187
Quantity per Package
10
Contains DI Package
10190302004183
Package Discontinue Date
April 17, 2020
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 | 634 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
3 | A medical device with high risk that requires premarket approval | 12 |