AccessGUDID - DEVICE: T-RING FLEX Digit Tourniquet (00869193000057)

GUDID

Device Identifier (DI) Information

Brand Name: T-RING FLEX Digit Tourniquet
Version or Model: TR002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRECISION MEDICAL DEVICES, LLC

Primary DI Number: 00869193000057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 786846571 *Terms of Use

Device Description: The T-RING FLEX is a non-pneumatic tourniquet for digits (fingers and toes). It is one size fits all, and automatically adjusts to the size of the digit to apply a safe and effective pressure (approximately 150 mm Hg). It is completely flexible and fits nicely in small spaces; i.e. pediatric fingers and toes.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
57827	Digit tourniquet, manual	An elastic ring designed to be applied to an injured digit (finger or toe) to provide immediate haemostasis and subsequent wound visualization. The elastic properties of the device enable it to automatically adjust to the size of the digit to which it is applied and to provide pressure to stem the flow of blood producing a bloodless field for emergent and elective procedures. It is typically used in emergency departments, operating rooms (OR) for finger/toe surgery, by first responders [medical centres and emergency medical services (EMS)], and in environments where sharp utensils are used (e.g., restaurants, butcher shops). 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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 2c49b096-d272-44c6-8c33-53faee1ebe43
Public Version Date: June 19, 2025
Public Version Number: 1
DI Record Publish Date: June 11, 2025