Trinity Sterile, Inc.

Basic Information

• Brand Name: Trinity Sterile, Inc.
• Primary DI: 40841767199846
• Version / Model: 10039
• Company Name: Trinity Sterile, Inc.
• Labeler DUNS: 154424043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-07
• Public Version: 2
• Public Version Date: 2023-10-24
• Public Version Status: Update
• Public Device Record Key: 8e0fa156-4001-4e93-8f2d-73afd6b9af88

Device Description

TOURNIQUET R&B 3/4X12

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
47949	Tourniquet cuff bandage, non-latex	A sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00841767199848	GS1		1000	In Commercial Distribution
Primary	40841767199846	GS1