GUDID 14987718300093

ANZAI MEDICAL CO., LTD.

Accelerator system synchronizer

• Primary Device ID: 14987718300093
• NIH Device Record Key: 5739ea7f-3310-442e-8771-69985c02636b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AZ-733V
• Company DUNS: 701259533
• Company Name: ANZAI MEDICAL CO., LTD.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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: +8137791611
• Email: info@anzai-med.co.jp
• Phone: +8137791611
• Email: info@anzai-med.co.jp

Device Identifiers

Device Issuing Agency	Device ID
GS1	14987718300093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031385

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

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: 2016-09-10

Devices Manufactured by ANZAI MEDICAL CO., LTD.

• 14987718300093 - NA: 2018-07-06
• 14987718300093 - NA: 2018-07-06
• 14987718300246 - NA: 2018-07-06
• 14987718300253 - NA: 2018-07-06