Dukal

Basic Information

• Brand Name: Dukal
• Primary DI: 10665973016259
• Version / Model: 385XL
• Catalog Number: 385XL
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2025-05-09
• Public Version Status: Update
• Public Device Record Key: 73e14c67-974c-456b-ade8-9986bbca7d31
• Distribution End Date: 2025-05-08

Device Description

Scrub Shirt, SMS, XL, Dark Blue

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
58382	Scrub suit, single-use	A two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20665973016256	GS1	Case	5	Not in Commercial Distribution	2025-05-08
Primary	10665973016259	GS1
Unit of Use	30665973016253	GS1

Customer Contacts

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