GammaBeam

GUDID 07540146000074

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

Best Theratronics Ltd

Teletherapy radionuclide system, conventional

• Primary Device ID: 07540146000074
• NIH Device Record Key: b5c46106-94d9-4f6f-945e-9ddbd5336969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaBeam
• Version Model Number: 500
• 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	07540146000074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150191

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 [GammaBeam]

• 00754014600076: A Cobalt Teletherapy device by which gamma radiation is delivered for the treatment of cancer
• 00754014600069: A Cobalt Teletherapydevice by which gamma radiation is delivered for the treatment of cancer
• 07540146000074: A Cobalt Teletherapy device by which gamma radiation is delivered for the treatment of cancer
• 07540146000067: A Cobalt Teletherapydevice by which gamma radiation is delivered for the treatment of cancer