Duns Number:330961223
Device Description: Hospital Device
Catalog Number
-
Brand Name
Trumpf Medical
Version/Model Number
1593158
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
-
Product Code
KXJ
Product Code Name
Table, radiologic
Public Device Record Key
6c392a9f-6370-4e93-bf5d-8c8d05f6e360
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 17, 2016
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 | 624 |
2 | A medical device with a moderate to high risk that requires special controls. | 48 |