Duns Number:009120817
Catalog Number
-
Brand Name
Varian Collimator Accessories Lower port film graticule for MLC
Version/Model Number
89004003
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
K171733,K181404
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
53a614c6-3d6a-47d4-9f15-1d002df50232
Public Version Date
June 07, 2021
Public Version Number
1
DI Record Publish Date
May 29, 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 |