EVOLVE SENSOR 16000004525

GUDID 07899581344701

Size 2

Alliage S/A Indústrias Médico Odontológica

Dental digital imaging sensor, intraoral

• Primary Device ID: 07899581344701
• NIH Device Record Key: c9f0132b-b169-406d-8c8c-afb89f9b34fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLVE SENSOR
• Version Model Number: EAGLE S
• Catalog Number: 16000004525
• Company DUNS: 898231451
• Company Name: Alliage S/A Indústrias Médico Odontológica
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.1 KiloPascal and 101.3 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581344701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230732

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: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [EVOLVE SENSOR]

• 07899581344701: Size 2
• 07899581344695: Size 1