AccessGUDID - DEVICE: SOF® TOURNIQUET NH, COLOR - RESCUE ORANGE (00818630011545)

GUDID

Device Identifier (DI) Information

Brand Name: SOF® TOURNIQUET NH, COLOR - RESCUE ORANGE
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SOFTT-R
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00818630011545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: Among tourniquet brands, the SOF® Tactical Tourniquet is one of the top performing medical tourniquets currently available. It is the tourniquet of choice for many of the world's most elite and experienced warriors who have selected it for its outstanding ability to control severe bleeding, high level of reliability and ease of application. While some military units have replaced their issued tourniquets with the SOF®TT, other military units (including special forces) have implemented SOP's stating that the SOF® Tactical Tourniquet is to be used on all lower extremity bleeds. That means the SOF®TT is the tourniquet trusted to control the most severe extremity hemorrhage on the battlefield. The key to successful implementation of a device to be used in a high stress environment is training and ease of use. For law enforcement officers, application of the tourniquet is similar to the use of a hobble. This existing level of familiarity reduces training time and aids in the effectiveness of the device. ADVANTAGES OF THE SOF® TACTICAL TOURNIQUET 100% Effective. Proven to be 100% effective during US Army Institute of Surgical Research testing. Simple application. Unlike other tactical medical tourniquets that require you to learn two methods of application and implement the proper method when under stress, the SOF®TT is applied the same way to an arm or leg. By accounting for the factors of human performance in combat, we have minimized the risk of failure. Applying a tourniquet should not be a multiple choice exam; It should be simple and straight forward. The SOF®TT provides the necessary effectiveness with an unmatched level of simplicity to increase the overall effectiveness of the device. Durability. The SOF®TT is constructed of quality, high-strength materials. The special forces tourniquet handle is machined from a solid piece of aircraft aluminum and maintains its strength in extreme temperatures. The tri-rings are molded Acetyl, a high impact plastic tha

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAX	Tourniquet, Nonpneumatic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef7d6265-a444-461f-8340-5fce1b09f33a
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: April 21, 2021