Duns Number:313217003
Catalog Number
-
Brand Name
SOMATOM go.Open Pro
Version/Model Number
11061670
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
K192061,K211373
Product Code
JAK
Product Code Name
System, x-ray, tomography, computed
Public Device Record Key
4a156e9f-1e34-417c-a1c3-7f8429a17ab2
Public Version Date
November 17, 2021
Public Version Number
4
DI Record Publish Date
December 19, 2019
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 478 |
3 | A medical device with high risk that requires premarket approval | 1 |