Duns Number:418153144
Device Description: Measuring unit for the dose calibrator
Catalog Number
-
Brand Name
VIK203
Version/Model Number
0202020091
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
KPT
Product Code Name
Calibrator, dose, radionuclide
Public Device Record Key
99f25515-945b-48c7-b96f-4465629d9d8a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 06, 2018
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. | 4 |