FDA UDI In Commercial Distribution 🇺🇸 United States

SOF® TOURNIQUET GEN 4, COLOR-ORANGE

DI: 00818630011552 · Model: 4 · TACTICAL MEDICAL SOLUTIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SOF® TOURNIQUET GEN 4, COLOR-ORANGE
Primary DI
00818630011552
Version / Model
4
Catalog Number
SOFTT-W-R
Company Name
TACTICAL MEDICAL SOLUTIONS, LLC
Labeler DUNS
131480662
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-22
Public Version
3
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
a1367bfc-7105-45db-afcc-e8b8ecde87a7

Device 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

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GAX Tourniquet, Nonpneumatic

GMDN Terms

Code Name
58128 Limb tourniquet, manual, single-use

Identifiers

Type ID
Primary 00818630011552

Customer Contacts

Phone
864-224-0081