Intraoral Dental Digital Imaging Sensor 16000004138

GUDID 07899581340284

Size 2

Alliage S/A Indústrias Médico Odontológica

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• Primary Device ID: 07899581340284
• NIH Device Record Key: 0828e99f-421e-4434-b7cb-7eef094d2500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraoral Dental Digital Imaging Sensor
• Version Model Number: Saevo Slim
• Catalog Number: 16000004138
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 79.7 KiloPascal and 101.3 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581340284 [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: 2023-10-26
• Device Publish Date: 2023-10-18

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