DEVICE: SOF® TOURNIQUET GEN 4, COLOR-BLACK (00818630011569)

Device Identifier (DI) Information

SOF® TOURNIQUET GEN 4, COLOR-BLACK
4
In Commercial Distribution
SOFTT-W
TACTICAL MEDICAL SOLUTIONS, LLC
00818630011569
GS1

1
131480662 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58128 Limb tourniquet, manual, single-use
A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It typically does not include latex and may be available in a variety of designs (e.g., Velcro or a self-locking buckle, synthetic rubber band). This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GAX Tourniquet, Nonpneumatic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1eb790bf-2f8d-4fa5-8b79-5695f5cb1887
June 10, 2022
3
October 22, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
864-224-0081
info@tacmedsolutions.com
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