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    FDA UDI In Commercial Distribution 🇺🇸 United States

    SOF® TOURNIQUET GEN 4, CANADIAN RED CROSS VERSION, COLOR-RED

    DI: 00818630013952 · Model: 4 · TACTICAL MEDICAL SOLUTIONS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SOF® TOURNIQUET GEN 4, CANADIAN RED CROSS VERSION, COLOR-RED
    Primary DI
    00818630013952
    Version / Model
    4
    Catalog Number
    SOFTT-W-CRC
    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
    11448e81-9da5-4346-980e-420df57a7dee

    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 00818630013952

    Customer Contacts

    Phone
    864-224-0081
    Email
    [email protected]