Duns Number:023260604
Catalog Number
-
Brand Name
Genesis Touch Tab A
Version/Model Number
6055423B1
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
K141792
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
368e043b-f4f0-4e5f-8fb6-1d7204421ac6
Public Version Date
October 26, 2022
Public Version Number
3
DI Record Publish Date
December 03, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |