Duns Number:131480662
Device Description: The SOF® Tourniquet Generation 4 (SOF®TT-W) is a true generational upgrade to the most eff The SOF® Tourniquet Generation 4 (SOF®TT-W) is a true generational upgrade to the most effective windlass tourniquet on the market featuring 4 key upgrades:TRAC - Tourniquet Retention Assistance ClipThe TRAC assists in applications by providing a temporary control point to hold the windlass while engaging the tri-ring, resulting in faster application times and doubling the security of the device in combination with the tri-ring during patient movements. This is especially helpful in one-handed applications and for those who do not have much experience applying tourniquets. The TRAC is an optional accessory for application, and the windlass must still be secured in the tri-ring for proper use. 2. 5.5" Windlass The increase in length eases the process of securing the windlass into the clip and tri-ring, increasing the effectiveness of the dual retention system. It still maintains its distinct conical ends while being machined from a single piece of aircraft-grade aluminum bar stock and anodized to minimize the product's signature in a tactical environment. 3. Quick-Compression BuckleThe Quick-Compression Buckle, added to the tourniquet last year, allows for smoother buckle manipulation due to its rounded edges. This also allows for easier one-handed application and overall faster application time. 4. Reinforced MaterialYes, we found a way to make the strongest tourniquet even stronger.The SOF® Tourniquet Gen 4 is built upon its original ruggedness and durability, which was the result of an exhaustive 24-month research initiative compiling end-user research and laboratory studies. The tourniquet is comprised of high-strength, lightweight alloy components. Its design allows the tourniquet to slide over a limb or, if the limb is trapped, the tourniquet can be rapidly disconnected and reconnected around the limb without rethreading the strap. With one application method for both the arm and the leg, the Gen 4 is the easiest tourniquet to operate
Catalog Number
SOFTT-W
Brand Name
SOF® TOURNIQUET GEN 4, COLOR-BLACK
Version/Model Number
4
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
1eb790bf-2f8d-4fa5-8b79-5695f5cb1887
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 22, 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 | 39 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |