BELRAY II AR-97WKCNJ6

GUDID 04952195093908

097 X-RAY WK with 26"Arm

TAKARA-BELMONT CO., LTD.

Stationary intraoral dental x-ray system, analogue

• Primary Device ID: 04952195093908
• NIH Device Record Key: 4e1556a7-f2ce-409a-97a6-41a0e3d5bd5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BELRAY II
• Version Model Number: 097
• Catalog Number: AR-97WKCNJ6
• 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 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04952195093908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093240

FDA Product Code

• EHD: UNIT, X-RAY, EXTRAORAL WITH TIMER

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 [BELRAY II]

• 04952195093939: 097 X-RAY WK with 40"Arm
• 04952195093922: 097 X-RAY WK with 12"Arm
• 04952195093915: 097 X-RAY WK with 20"Arm
• 04952195093908: 097 X-RAY WK with 26"Arm
• 04952195093809: 097 X-RAY WK with 31"Arm