Duns Number:001180207
Device Description: SOFT-T XS Tourniquet
Catalog Number
91097
Brand Name
First Aid Only
Version/Model Number
91097
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAX
Product Code Name
Tourniquet, Nonpneumatic
Public Device Record Key
c28ba043-bec5-4546-af91-80d21c274561
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 26, 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 | 303 |