AccessGUDID - DEVICE: Tourni-Cot - Medium (00855364004047)

GUDID

Device Identifier (DI) Information

Brand Name: Tourni-Cot - Medium
Version or Model: TCM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAR-MED INC.

Primary DI Number: 00855364004047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176664068 *Terms of Use

Device Description: Exsanguinating digital tourniquets to create a bloodless field for procedures on 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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
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 [?]
K853472	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 17a62c5a-19a1-4bef-b418-4fefe098b2d3
Public Version Date: January 31, 2025
Public Version Number: 3
DI Record Publish Date: September 23, 2020