ProBeam Proton Therapy System

GUDID 00858991006002

Rotating Gantry

Varian Medical Systems Particle Therapy GmbH

Proton therapy system

• Primary Device ID: 00858991006002
• NIH Device Record Key: e651e8e5-9e5a-49d6-8ca4-872d9e0d5f87
• 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	00858991006002 [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