Novalis Tx

GUDID 00899475002080

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system 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.

• 00856100006158 - Visual Coaching Device (VCD): 2023-11-22
• 00850800006067 - VariSeed: 2023-09-25
• 00858086006801 - IDENTIFY: 2023-08-14
• 00855141006202 - Eclipse Treatment Planning System: 2023-08-07
• 00899475002042 - Clinac iX: 2023-06-20
• 00899475002066 - Trilogy: 2023-06-20
• 00899475002080 - Novalis Tx: 2023-06-20
• 00899475002080 - Novalis Tx: 2023-06-20
• 00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US: 2023-05-29