DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756760300
• Version / Model: 19-202A-02
• Catalog Number: 19-202A-02
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-21
• Public Version: 1
• Public Version Date: 2021-07-29
• Public Version Status: New
• Public Device Record Key: 0b5bfe0b-558d-444c-a108-1262811ca6f3

Device Description

SHOULDER IMMOBILIZER

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQI	ORTHOSIS, LIMB BRACE	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41465	Shoulder orthosis	An externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the shoulder. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756760300	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]