Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 10665973003372
• Version / Model: 350
• Catalog Number: 350
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: f6788e2c-b3eb-4469-86ec-caf24bd52d61
• Distribution End Date: 2023-08-29

Device Description

Non-Skid Shoe Cover

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
FXP	COVER, SHOE, OPERATING-ROOM	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20665973003379	GS1	Case	3	Not in Commercial Distribution	2023-08-29
Primary	10665973003372	GS1
Unit of Use	00665973003375	GS1

Customer Contacts

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