Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 10665973003327
• Version / Model: 382XXL
• Catalog Number: 382XXL
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 1
• Public Version Date: 2022-12-14
• Public Version Status: New
• Public Device Record Key: 968c4aab-0886-44b1-9acd-4472b74dc6a8

Device Description

Coveralls XXL, White

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
LYU	ACCESSORY, SURGICAL APPAREL	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65414	Surgical coverall	A single-piece, fluid-resistant garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, legs, and head during a surgical procedure or for other appropriate medical reasons. Also known as a jump suit, it is used to help protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material; it may include separate shoe covers. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20665973003324	GS1	Case	5	In Commercial Distribution
Primary	10665973003327	GS1
Unit of Use	00665973003320	GS1

Customer Contacts

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