UniRay

Basic Information

• Brand Name: UniRay
• Primary DI: 08904333252544
• Version / Model: DFD00104
• Company Name: UNIRAY MEDICAL LLP
• Labeler DUNS: 650843316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-18
• Public Version: 1
• Public Version Date: 2023-02-27
• Public Version Status: New
• Public Device Record Key: ec01167f-a65b-4192-86a0-01b7d47580d9

Device Description

Dental X-Ray Plate Size 4

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: No
• 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
LMB	Device, Digital Image Storage, Radiological	Radiology	892.2010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44826	Digital imaging storage phosphor screen	A photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08904333252544	GS1