Novalis Tx

GUDID 00899475002080

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system

• Primary Device ID: 00899475002080
• NIH Device Record Key: 50728f60-f298-4680-9cda-ceec099a1899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novalis Tx
• Version Model Number: 9.1
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899475002080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131807

FDA Product Code

• IYE: Accelerator, linear, 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: 4
• Public Version Date: 2023-06-20
• Device Publish Date: 2016-09-10

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