Veraviewepocs

GUDID 04548213020379

J.MORITA MFG.CORP.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 04548213020379
• NIH Device Record Key: 9f7078a3-7493-4540-9d76-39652ff536ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veraviewepocs
• Version Model Number: X550
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.CORP.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548213020379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073696

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: 2020-03-30
• Device Publish Date: 2020-03-21

On-Brand Devices [Veraviewepocs]

• 04548213026432: X-550
• 04548213013708: X-550
• 04548213020379: X550