← Back to catalogue
Softt-W - Sof Tactical Tourniquet, 1.5", Black (gen 4)
EUDAMEDFDA UDIClass I (EU MDR)
Ref SOFTT-W
Identity
- Trade Name
- SOFTT-W - SOF TACTICAL TOURNIQUET, 1.5", BLACK (GEN 4) EUDAMEDSOF® TOURNIQUET GEN 4, COLOR-BLACK FDA UDI
- Generic Name
- Limb tourniquet, manual, single-use FDA UDI
- Device Name
- SOF® TACTICAL TOURNIQUET EUDAMEDThe 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
- SOFTT-W EUDAMED4 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 FDA UDI
- Primary DI / UDI-DI
- 00818630011569 EUDAMEDFDA UDI
- Basic UDI-DI
- 081863001TMSTourniquets96 EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Limb tourniquet, manual, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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, reusable
Softt-W - Sof Tactical Tourniquet, 1.5", Black (gen 4) by TacMed Solutions, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Limb tourniquet, manual, reusable.
- 10 cm x 3, 5 mt. İdeal Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- 15 cm x 5 mt. Elastik Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- Opaska zaciskowa — ChM spółka z ograniczoną odpowiedzialnością · Class I
- 15 cm x 5 mt. Ten Rengi İdeal Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- TOURNIQUET — ZHENGZHOU MEDCONS IMPORT&EXPORT TRADING CO.,LTD · Class I
- garrot militaire combat application toueniquet — Danyang Sunmed Healthcare Corporation · Class I
- Constricting band — EMSRUN GROUP · Class I
- 200 Single use tourniquets InControl brand — ASEP HEALTHCARE LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081863001TMSTourniquets96 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TacMed Solutions, LLC
- EUDAMED SRN
- US-MF-000042757
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED e704324c-e343-43f6-a1be-3adcff52e6ee 61 fields · synced Jun 18, 2026
- FDA UDI 1eb790bf-2f8d-4fa5-8b79-5695f5cb1887 35 fields · synced May 30, 2026