Identity
- Trade Name
- SOF Tourniquet, Red EUDAMEDSOF® TOURNIQUET RED CROSS VERSION FDA UDI
- Generic Name
- Limb tourniquet, manual, single-use FDA UDI
- Device Name
- SOF® TACTICAL TOURNIQUET EUDAMEDTHE NEW BENCHMARK FOR BLEEDING CONTROL The 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. FDA UDI
- Model / Reference
- 84-0013 EUDAMED5 FDA UDI
- Description
- THE NEW BENCHMARK FOR BLEEDING CONTROL The 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. FDA UDI
Identifiers
- Catalog Number
- 84-0013 FDA UDI
- Primary DI / UDI-DI
- 00818630015482 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
- Germany 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
SOF Tourniquet, Red by TacMed Solutions, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- TacMed Solutions, LLC
- EUDAMED SRN
- US-MF-000042757
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED c8af8027-9952-4e24-9a12-8c5b94d8c7ed 61 fields · synced Jun 18, 2026
- FDA UDI ef69528e-775d-4a3f-91bf-b159c8f7d8e2 35 fields · synced May 24, 2026