Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 10665973022410
• Version / Model: 4409
• Catalog Number: 4409
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-05-30
• Public Version: 2
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: 3dfc34ae-f41c-4aad-bf31-5300b65de244

Device Description

Latex Tourniquet 1"x18"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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	Emergency 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 bleeding (e.g., in a military setting and/or high-risk work environment); it may additionally be used in non-life-threatening injuries. 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	20665973022417	GS1	Case	10	In Commercial Distribution
Primary	10665973022410	GS1
Unit of Use	00665973022413	GS1

Customer Contacts

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