Theratron

GUDID 07540146000036

A Cobalt Teletherapydevice by which gamma radiation is delivered for the treatment of cancer

Best Theratronics Ltd

Teletherapy radionuclide system, conventional

• Primary Device ID: 07540146000036
• NIH Device Record Key: 83c42e52-34aa-4a37-90ee-51447b29122c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Theratron
• Version Model Number: Equinox
• Company DUNS: 243606832
• Company Name: Best Theratronics 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: 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: 6135912100
• Email: compliance@theratronics.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540146000036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053485

FDA Product Code

• IWB: System, Radiation Therapy, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2016-10-14

On-Brand Devices [Theratron]

• 00754014600038: A Cobalt Teletherapydevice by which gamma radiation is delivered for the treatment of cancer
• 07540146000036: A Cobalt Teletherapydevice by which gamma radiation is delivered for the treatment of cancer