KaVo GXS-700 Sensor Size 2 1.012.8978

GUDID EKAV101289780

Size 2

GENDEX CORP.

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: EKAV101289780
• NIH Device Record Key: 0fd641f2-e723-4b4e-95d0-59a4082ac1bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo GXS-700 Sensor Size 2
• Version Model Number: 1.012.8978
• Catalog Number: 1.012.8978
• Company DUNS: 144575763
• Company Name: GENDEX CORP.
• Device Count: 1
• DM Exempt: true
• 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: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com
• Phone: +18003238029
• Email: info@gendex.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101289780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090458

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: 2018-11-08
• Device Publish Date: 2018-10-08

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