DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756876735
• Version / Model: 11632000
• Catalog Number: 11632000
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-20
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: ff155f30-fcd3-4a1e-b983-a45cb0a969d3

Device Description

RIGHT, WARRIOR® WING

Device Characteristics

• Single Use: Yes
• 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
IOY	SUPPORT, ARM	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44878	Shoulder immobilizer/orthosis, single-use	A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756876735	GS1

Customer Contacts

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