Duns Number:365355452
Catalog Number
-
Brand Name
Oxoid Meropenem/Vaborbactam Antimicrobial Susceptibility Discs
Version/Model Number
CT1949B
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JTN
Product Code Name
Susceptibility Test Discs, Antimicrobial
Public Device Record Key
40522ac9-1f76-4a8b-88af-5116c1421f03
Public Version Date
January 17, 2020
Public Version Number
1
DI Record Publish Date
January 09, 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. | 25 |