Identity
- Trade Name
- SOF® TOURNIQUET GEN 4, COLOR-BLUE FDA UDI
- Generic Name
- Limb tourniquet, manual, single-use FDA UDI
- Device Name
- 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 Clip The 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 Buckle The 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 Material Yes, 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 FDA UDI
- Model / Reference
- 4 FDA UDI
- Description
- 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 Clip The 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 Buckle The 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 Material Yes, 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 FDA UDI
Identifiers
- Catalog Number
- SOFTT-W-TRN FDA UDI
- Primary DI / UDI-DI
- 00818630011576 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Limb tourniquet, manual, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Limb tourniquet, manual, single-use
Sof® Tourniquet Gen 4, Color-Blue by Tactical Medical Solutions, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tactical Medical Solutions, Llc
Sources (1)
- FDA UDI 09f8762f-22f5-4275-a510-8a93fb4abbf9 35 fields · synced May 30, 2026