Duns Number:131480662
Device Description: THE NEW BENCHMARK FOR BLEEDING CONTROLThe newest evolution of the SOF® Tourniquet sets the THE NEW BENCHMARK FOR BLEEDING CONTROLThe newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control.Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb.In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you.Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
Catalog Number
84-0010
Brand Name
SOF® TOURNIQUET COLOR - RESCUE ORANGE
Version/Model Number
5
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)
-
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
620493ad-6c8e-4d6e-a449-ff9d250feaee
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 21, 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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |