DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756040990
• Version / Model: 10-929
• Catalog Number: 10-929
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-02
• Public Version: 1
• Public Version Date: 2023-02-10
• Public Version Status: New
• Public Device Record Key: cf9cb347-753f-4687-8a5c-4d2f1add49ad

Device Description

ST. BURN KIT ADULT SMALL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJJ	Burn kit without drug	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10516	Burn kit, non-medicated	A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50749756040995	GS1	CA	15	In Commercial Distribution
Primary	00749756040990	GS1