BELMAX CM BELMAX CM-US

GUDID 04560217093616

BELMAX CM DIGITAL PANORAMIC AND CEPHALOMETRIC X-RAY(R)

TAKARA-BELMONT CO., LTD.

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• Primary Device ID: 04560217093616
• NIH Device Record Key: dd914f08-9431-4f66-8433-ffdb6dc33c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BELMAX CM
• Version Model Number: BELMAX(R)
• Catalog Number: BELMAX CM-US
• Company DUNS: 690540349
• Company Name: TAKARA-BELMONT CO., LTD.
• 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: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com
• Phone: +1(800)223-1192
• Email: gstern@belmontequip.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560217093616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062529

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [BELMAX CM]

• 04560217094552: BELMAX CM DIGITAL PANORAMIC AND CEPHALOMETRIC X-RAY(L)
• 04560217093616: BELMAX CM DIGITAL PANORAMIC AND CEPHALOMETRIC X-RAY(R)