DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756085540
• Version / Model: 7091-12
• Catalog Number: 7091-12
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-29
• Public Version: 1
• Public Version Date: 2021-08-06
• Public Version Status: New
• Public Device Record Key: 8a154ef0-f155-404c-9d2a-2f1b856f973a

Device Description

KNEE BRACE

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
ITQ	JOINT, KNEE, EXTERNAL BRACE	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12099	Knee immobilizer	A rigid support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756085540	GS1

Customer Contacts

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