Portable

GUDID 07540146000098

MOSFET radiation therapy dosimetry system

Best Medical Canada Ltd

MOSFET radiation therapy dosimetry system

• Primary Device ID: 07540146000098
• NIH Device Record Key: 1e5b643f-3783-405d-9fa5-ab791bce9cf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable
• Version Model Number: Dosimeter
• Company DUNS: 247902336
• Company Name: Best Medical Canada 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	07540146000098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092285

FDA Product Code

• IYE: Accelerator, Linear, 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: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2016-09-30

On-Brand Devices [Portable]

• 00754014600090: MOSFET radiation therapy dosimetry system
• 07540146000098: MOSFET radiation therapy dosimetry system