Duns Number:009120817
Catalog Number
GM11013320
Brand Name
Varian Universal Interstitial Cylinder, 30mm diameter
Version/Model Number
GM11013320
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K193240
Product Code
JAQ
Product Code Name
System, applicator, radionuclide, remote-controlled
Public Device Record Key
9d24a99e-8b34-4ae5-8660-bf84ceeb1a4f
Public Version Date
March 03, 2021
Public Version Number
1
DI Record Publish Date
February 23, 2021
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 |
---|---|---|
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 |