BELMAX CM BELMAX CM-US

GUDID 04560217094552

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

TAKARA-BELMONT CO., LTD.

Stationary panoramic dental x-ray system, digital

• Primary Device ID: 04560217094552
• NIH Device Record Key: bb91d1e6-e227-4963-9571-1afb7231e367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BELMAX CM
• Version Model Number: BELMAX(L)
• 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: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp
• Phone: +810662135945
• Email: e-nishizawa@belmont.jp

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560217094552 [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)