DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756005968
• Version / Model: 3015-01
• Catalog Number: 3015-01
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-23
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 55391c05-789c-4b8d-8779-bbd55360eddf

Device Description

CLAVICLE STRAP

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
IQJ	SPLINT, CLAVICLE	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13810	Clavicle orthosis	A prefabricated (non-customized) wearable device intended to be worn over the shoulders of a patient to provide support and protection to a clavicle bone which has been fractured or injured. It is formed as a figure-of-eight harness that descends from the shoulders, passes under each arm and crosses over the back. It has broad, padded straps and may have extra padding inserted at the back. This device may also be used to improve the patient's posture. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756005968	GS1

Customer Contacts

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