VariSeed 9.0

GUDID 00850800006005

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software

• Primary Device ID: 00850800006005
• NIH Device Record Key: 88720685-7cc2-441a-a6e0-872dfb37aea4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariSeed 9.0
• Version Model Number: 9.0
• Company DUNS: 035520894
• 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: false
• Manufacturing Date: false
• 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	00850800006005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150636

FDA Product Code

• MUJ: System,planning,radiation therapy treatment

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: 2016-11-08

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00857235006082 - Halcyon: 2026-02-03
• 00857235006105 - Ethos Radiotherapy System: 2026-02-03
• 00858086006771 - TrueBeam: 2026-01-23
• 00858086006788 - VitalBeam: 2026-01-23
• 00858086006795 - EDGE: 2026-01-23
• 00858086006825 - TrueBeam STx: 2026-01-23
• 00899475002110 - High-Definition 120 Multileaf Collimator: 2026-01-14
• 00857235006075 - Halcyon: 2026-01-13