RiX70 DC RIX70DC-000

GUDID 08055060430191

The RiX 70 DC Mobile is an X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.

TRIDENT SRL

Mobile intraoral dental x-ray system, digital

• Primary Device ID: 08055060430191
• NIH Device Record Key: 3592a5c2-ba8b-4d13-a55c-cba8b1baa70b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RiX70 DC
• Version Model Number: Mobile version
• Catalog Number: RIX70DC-000
• Company DUNS: 430142798
• Company Name: TRIDENT 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: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com
• Phone: (904) 477-3203
• Email: joyce510kfda@gmail.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08055060430191 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-15
• Device Publish Date: 2020-09-07

On-Brand Devices [RiX70 DC]

• 08055060430221: The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of
• 08055060430191: The RiX 70 DC Mobile is an X-Ray source to produce intraoral images for the diagnosis of teeth a
• 08055060430177: The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of
• 08055060430160: The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of