Duns Number:103977526
Device Description: For use with Siemens Vario 2 CT
Catalog Number
MTIL600812
Brand Name
Docking Station
Version/Model Number
MTIL600812
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180021
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
57db9b75-192e-4bb8-83f8-01c82dcad98f
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 05, 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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 1027 |