Duns Number:380807099
Device Description: Gating Module for Varian TrueBream
Catalog Number
SDX0366V1.0
Brand Name
SDX System
Version/Model Number
V1.0
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
K121845
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
aa8974ad-f580-46b7-9edd-10ce42479cfe
Public Version Date
November 02, 2018
Public Version Number
1
DI Record Publish Date
October 02, 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. | 16 |