DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756268998
• Version / Model: 13760406
• Catalog Number: 13760406
• 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: 73577134-0566-4bdb-8d12-2073648e6018

Device Description

RIB BELT

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
FSD	BINDER, ABDOMINAL	General Hospital	880.5160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44848	Rib/sternum binder, single-use	A strip or roll of fabric or plastic material designed to support the sternum (the breastbone), ribs, and chest (e.g., to support a sternum/rib fracture or support the chest post cardiothoracic surgery). It may be referred to as a chest binder or sternum splint. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756268998	GS1

Customer Contacts

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