ProBeam® Rotating Gantry Proton Therapy System

GUDID 00858991006033

Rotating Gantry

Varian Medical Systems Particle Therapy GmbH

Proton therapy system

• Primary Device ID: 00858991006033
• NIH Device Record Key: 17a777cf-0d28-4142-b837-89a2c3aafee1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBeam® Rotating Gantry Proton Therapy System
• Version Model Number: 3.5
• 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	00858991006033 [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: 2
• Public Version Date: 2019-10-04
• Device Publish Date: 2019-09-12

On-Brand Devices [ProBeam® Rotating Gantry Proton Therapy System]

• 00858991006040: 4.2
• 00858991006033: Rotating Gantry