ProBeam® Proton Therapy System - Rotating Gantry

GUDID 00858991006057

VARIAN MEDICAL SYSTEMS, INC.

Proton therapy system

• Primary Device ID: 00858991006057
• NIH Device Record Key: 1978912b-b8d8-408c-a2a3-0b2b39ded525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBeam® Proton Therapy System - Rotating Gantry
• Version Model Number: 4.3
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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	00858991006057 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 10810563022725 - OmniBone Bone Biopsy Kit with 11 Gauge 68mm length: 2025-09-26
• 10810563022732 - OmniBone Bone Biopsy Kit with 11 Gauge 108mm length: 2025-09-26
• 10810563022749 - OmniBone Bone Biopsy Kit with 11 Gauge 158mm length: 2025-09-26
• 10810563022824 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm: 2025-09-26
• 10810563023036 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm: 2025-09-26
• 00810563023046 - OmniBone Power Driver: 2025-09-26
• 00810563023053 - OmniBone Charger: 2025-09-26
• 00810563023060 - OmniBone Power Driver and Charger: 2025-09-26