Intraoral X-ray sensor

GUDID 08800060100052

Re-medi Co.,LTD

Dental digital imaging sensor, intraoral

• Primary Device ID: 08800060100052
• NIH Device Record Key: fb6fb7c0-bc4d-42e3-9f4f-b7c2eaa93a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraoral X-ray sensor
• Version Model Number: IoDS-2401
• Company DUNS: 690072489
• Company Name: Re-medi Co.,LTD
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 76 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800060100052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200284

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: 2020-10-20
• Device Publish Date: 2020-10-12

On-Brand Devices [Intraoral X-ray sensor]

• 08800060100069: IoDS-2402
• 08800060100052: IoDS-2401