Duns Number:863318313
Catalog Number
-
Brand Name
Varian Verification Console
Version/Model Number
2.3
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
K124002
Product Code
LHN
Product Code Name
System, radiation therapy, charged-particle, medical
Public Device Record Key
3eb2f067-3bb1-4606-93ad-4cff4cd15798
Public Version Date
November 18, 2019
Public Version Number
1
DI Record Publish Date
November 08, 2019
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. | 5 |