IntraOs DG

GUDID E31593250013000

Intraoral X-ray unit (70 kV, 3.5 mA), sensor not included

FONA SRL

Mobile intraoral dental x-ray system, digital

• Primary Device ID: E31593250013000
• NIH Device Record Key: b65b3463-f893-41cd-bed9-1b121ccc852c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraOs DG
• Version Model Number: 9325001300
• Company DUNS: 514320345
• Company Name: FONA SRL
• 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: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it
• Phone: +390245712171
• Email: info@fonadental.it

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E31593250013000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031118

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2018-07-06
• Device Publish Date: 2016-09-10

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• E3158468600000 - Stellaris 3D: 2022-05-09
• E3158468600002 - Stellaris 3D Ceph: 2022-05-09
• E3158468600007 - Stellaris 2D: 2022-05-09
• E3158468600008 - Stellaris 2D Ceph: 2022-05-09