myray 70BA0000

GUDID 08033837932925

Digital panoramic, cephalometric extra-oral X-ray system. Cephalometric arm is optional.

CEFLA SOCIETA' COOPERATIVA

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08033837932925
• NIH Device Record Key: c08f4067-5293-4481-8098-2c6d38910e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myray
• Version Model Number: hyperion X5 (2D CEPH)
• Catalog Number: 70BA0000
• Company DUNS: 429341410
• Company Name: CEFLA SOCIETA' COOPERATIVA
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1 (704)598-0020
• Email: service@cefladental.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837932925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200688

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-11
• Device Publish Date: 2020-05-03