NewTom P70700011

GUDID 08033837931348

X-ray imaging device comprising an X-ray acquisition system and the control box, for producing two and three dimensional views for computation and display.

CEFLA SOCIETA' COOPERATIVA

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• Primary Device ID: 08033837931348
• NIH Device Record Key: 1cae24ba-0094-4431-a65a-32a06ed370ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NewTom
• Version Model Number: NewTom VGi evo
• Catalog Number: P70700011
• 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
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com
• Phone: +1 (704)598-0020
• Email: service@cefladental.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837931348 [Primary]

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-06-19
• Device Publish Date: 2016-10-03