Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 00665973017228
• Version / Model: 263
• Catalog Number: 263
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 2dabcd0b-f846-4e20-b302-c848dd97a13b

Device Description

Plain Packing Strip 2" x 5yd

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFQ	GAUZE/SPONGE, INTERNAL	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
48128	Gauze strip, non-antimicrobial	A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10665973017225	GS1	Box	12	In Commercial Distribution
Primary	00665973017228	GS1
Package	20665973017222	GS1	Case	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K861154	000