ProBeam Proton Therapy System

GUDID 00858991006019

Fixed Beam

Varian Medical Systems Particle Therapy GmbH

Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system

• Primary Device ID: 00858991006019
• NIH Device Record Key: ec8997c5-d39f-4e0b-acac-3ddbaf75aaeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBeam Proton Therapy System
• Version Model Number: 3.0
• Company DUNS: 342623907
• Company Name: Varian Medical Systems Particle Therapy GmbH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858991006019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133191

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: 2016-09-21

On-Brand Devices [ProBeam Proton Therapy System]

• 00858991006019: Fixed Beam
• 00858991006002: Rotating Gantry