UniRay

Basic Information

• Brand Name: UniRay
• Primary DI: 08904333223018
• Version / Model: UF541300
• Company Name: UNIRAY MEDICAL LLP
• Labeler DUNS: 650843316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-11
• Public Version: 1
• Public Version Date: 2023-02-20
• Public Version Status: New
• Public Device Record Key: 879c73b6-89df-489d-bb12-a571b1c519e1

Device Description

Thyroid collar, Elegance - 0.5mm MaxLite

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: Yes
• 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
KPY	Shield, Protective, Personnel	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38358	Radiation shielding collar	A personal protective device intended to shield the neck area including the nape, the throat, and the thyroid of an individual (i.e., a device operator or other attending person) from unnecessary exposure to radiation during diagnostic or therapeutic medical and dental procedures. Collars used in x-ray and nuclear medicine typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Collars used for neutron attenuation are composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08904333223018	GS1