KaVo IXS Size 1 Sensor 10132914

GUDID EKAV101329140

This is a kit containing a medical device.

Imaging Sciences International

Dental digital imaging sensor, intraoral

• Primary Device ID: EKAV101329140
• NIH Device Record Key: 3159dc13-dff3-4cab-bd6d-7a1b26a1da58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo IXS Size 1 Sensor
• Version Model Number: 1.013.2914
• Catalog Number: 10132914
• Company DUNS: 800111106
• Company Name: Imaging Sciences International
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.com
• Phone: +18882755286
• Email: kkg.imaging.cs@kavokerr.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
• 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
• 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
• 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
• 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
• 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	EKAV101329140 [Primary]

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: 2020-03-25
• Device Publish Date: 2020-03-17

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