SuniRay2 400-1227-B

GUDID 00851067007002

The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire real‐time intra‐oral dental radiography images in combination with a dedicated dental Imaging Software. The Digital Radiography System is available either with a #2 or #1 sensor size. It is intended to be used by dentists to diagnose dental diseases.

SUNI MEDICAL IMAGING, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: 00851067007002
• NIH Device Record Key: 94f6c12c-1f38-4b0b-aaeb-766fe499f755
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuniRay2
• Version Model Number: Sensor size #2
• Catalog Number: 400-1227-B
• Company DUNS: 180451106
• Company Name: SUNI MEDICAL IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 408-227-6698
• Email: support@suni.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851067007002 [Primary]

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [SuniRay2 ]

• 00851067007019: The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire re
• 00851067007002: The SuniRay2 Digital Radiography System is a semiconductor imaging device intended to acquire re