DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756061483
• Version / Model: 27102
• Catalog Number: 27102
• 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: 1
• Public Version Date: 2021-08-02
• Public Version Status: New
• Public Device Record Key: 21e87fbf-bf61-4d48-8b15-6c9d5b0d8bdc

Device Description

BUCKS TRACTION BOOT

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
HSP	SPLINT, TRACTION	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46526	Traction system belt	A harness designed to provide traction to the lower spine, including the lumbar and pelvic areas, with force from an external traction system. It is typically a padded piece of material (e.g., cotton, vinyl) that is placed around the waist, and has one or more straps with rings at the end that permit its attachment to the traction system's cable. It may include additional rings for attachment to a spreader bar. The harness is used mainly for relief of low back pain and to maintain normal alignment of the vertebrae.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756061483	GS1

Customer Contacts

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