Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 20665973032409
• Version / Model: 4300OR
• Catalog Number: 4300OR
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2025-04-08
• Public Version: 1
• Public Version Date: 2025-04-16
• Public Version Status: New
• Public Device Record Key: 4d473da2-9ff9-4059-b5ad-b9b0f2a000d8

Device Description

Tourniquet, Non-Latex, 1"x18", Orange

Device Characteristics

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

Sterilization

• Is Sterile: No
• 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
67046	Arterial tourniquet, manual, single-use	A device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening (emergency) bleeding from an artery (e.g., in a military setting and/or high-risk work environment). It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30665973032406	GS1	Case	4	In Commercial Distribution
Primary	20665973032409	GS1
Unit of Use	00665973032405	GS1

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]