Duns Number:009120817
Catalog Number
-
Brand Name
Varian POST ASSY, STEREOTACTIC HEAD FRAME
Version/Model Number
10002738503
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
K180586,K180586
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
71db7eda-88ba-47c9-8f32-743b3660bb8b
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 19, 2021
Package DI Number
10899475002490
Quantity per Package
4
Contains DI Package
00899475002493
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 253 |