True Support Neck Brace

Basic Information

• Brand Name: True Support Neck Brace
• Primary DI: 00850027494500
• Version / Model: UNBrace
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-03
• Public Version: 1
• Public Version Date: 2023-11-13
• Public Version Status: New
• Public Device Record Key: bc661d16-f9c5-4b55-b394-7297a2deffb4

Device Description

Universal Neck Brace

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQK	Orthosis, Cervical	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41039	Cervical spine collar, reusable	A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850027494507	GS1	Outer Case	200	In Commercial Distribution
Primary	00850027494500	GS1

Customer Contacts

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