DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756013109
• Version / Model: 6101-01
• Catalog Number: 6101-01
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-29
• Public Version: 1
• Public Version Date: 2021-08-06
• Public Version Status: New
• Public Device Record Key: 0a05e6ea-332a-4b32-abb7-52be74a31a9e

Device Description

HEAD HALTER

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
HSS	HALTER, HEAD, TRACTION	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46527	Traction system head halter	A device designed to provide traction to the cervical vertebrae by pulling the head with force from an external traction system. It typically combines several padded straps in a lightweight structure; usually one of the straps is placed under the chin, a second one on the back of the head, and another strap goes around the neck to attach the two other straps together. The device includes one or more rings at the top that permit its attachment to the traction system's cable. It is intended for horizontal and/or vertical traction and is used in orthopaedic and/or physical therapy procedures, including fracture treatment and widening of the intervertebral spaces in the spine.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756013109	GS1

Customer Contacts

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