MOBETRON

GUDID 00861396000308

The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72

INTRAOP MEDICAL CORPORATION

Linear accelerator system

• Primary Device ID: 00861396000308
• NIH Device Record Key: 1df06bae-11c0-4e03-9d67-407e0fdf14a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOBETRON
• Version Model Number: MOBETRON
• Company DUNS: 079168716
• Company Name: INTRAOP MEDICAL CORPORATION
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 14086361020
• Email: anguyen@intraop.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861396000308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981112

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-15