Duns Number:072656713
Device Description: TK-4 Tourniquet, an elastic tourniquet with two S-hook ends, used to stop or slow severe h TK-4 Tourniquet, an elastic tourniquet with two S-hook ends, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss. Strap color is coyote tan
Catalog Number
TK-4
Brand Name
TK-4 Elastic Tourniquet
Version/Model Number
1
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"
Yes
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
1f5216f0-8c0b-4014-9f40-4b0616ddec88
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
December 31, 2020
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |