ProBeam 360 Proton Therapy System - Rotaiting Gantry

GUDID 00858991006071

Varian Medical Systems Particle Therapy GmbH

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• Primary Device ID: 00858991006071
• NIH Device Record Key: 7d06968b-1d16-4d2f-9819-fc5a6378c381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBeam 360 Proton Therapy System - Rotaiting Gantry
• Version Model Number: 1.0
• 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: true
• 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	00858991006071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221791

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: 2022-12-14
• Device Publish Date: 2022-12-06

Devices Manufactured by Varian Medical Systems Particle Therapy GmbH

• 00858991006088 - ProBeam 360 Proton Therapy System - Rotating Gantry: 2023-11-02
• 00858991006071 - ProBeam 360 Proton Therapy System - Rotaiting Gantry: 2022-12-14
• 00858991006071 - ProBeam 360 Proton Therapy System - Rotaiting Gantry: 2022-12-14
• 00858991006026 - ProBeam® Fixed Beam Proton Therapy System: 2019-10-04 Fixed Beam
• 00858991006033 - ProBeam® Rotating Gantry Proton Therapy System: 2019-10-04 Rotating Gantry
• 00858991006040 - ProBeam® Rotating Gantry Proton Therapy System: 2019-10-04
• 00858991006002 - ProBeam Proton Therapy System: 2018-07-06 Rotating Gantry
• 00858991006019 - ProBeam Proton Therapy System: 2018-07-06 Fixed Beam