Duns Number:131480662
Device Description: Among tourniquet brands, the SOF® Tactical Tourniquet is one of the top performing medical Among tourniquet brands, the SOF® Tactical Tourniquet is one of the top performing medical tourniquets currently available. It is the tourniquet of choice for many of the world's most elite and experienced warriors who have selected it for its outstanding ability to control severe bleeding, high level of reliability and ease of application. While some military units have replaced their issued tourniquets with the SOF®TT, other military units (including special forces) have implemented SOP's stating that the SOF® Tactical Tourniquet is to be used on all lower extremity bleeds. That means the SOF®TT is the tourniquet trusted to control the most severe extremity hemorrhage on the battlefield. The key to successful implementation of a device to be used in a high stress environment is training and ease of use. For law enforcement officers, application of the tourniquet is similar to the use of a hobble. This existing level of familiarity reduces training time and aids in the effectiveness of the device. ADVANTAGES OF THE SOF® TACTICAL TOURNIQUET 100% Effective. Proven to be 100% effective during US Army Institute of Surgical Research testing. Simple application. Unlike other tactical medical tourniquets that require you to learn two methods of application and implement the proper method when under stress, the SOF®TT is applied the same way to an arm or leg. By accounting for the factors of human performance in combat, we have minimized the risk of failure. Applying a tourniquet should not be a multiple choice exam; It should be simple and straight forward. The SOF®TT provides the necessary effectiveness with an unmatched level of simplicity to increase the overall effectiveness of the device. Durability. The SOF®TT is constructed of quality, high-strength materials. The special forces tourniquet handle is machined from a solid piece of aircraft aluminum and maintains its strength in extreme temperatures. The tri-rings are molded Acetyl, a high impact plastic tha
Catalog Number
SOFTT-NH-T
Brand Name
SOF® TOURNIQUET NH, COLOR - BLUE
Version/Model Number
2
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
97b5dd5e-f4d1-4112-9e66-25dfdc6bde25
Public Version Date
June 10, 2022
Public Version Number
3
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 |