Tourni-Cot - Universal

Basic Information

• Brand Name: Tourni-Cot - Universal
• Primary DI: 00855364004085
• Version / Model: TCU
• Company Name: MAR-MED INC.
• Labeler DUNS: 176664068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 90bd6d09-ac52-47ba-a869-e0f253925d18

Device Description

Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855364004085	GS1
Package	10855364004082	GS1	Box	20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K853472	000