Edge

GUDID 00899475002349

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system Linear accelerator system

• Primary Device ID: 00899475002349
• NIH Device Record Key: 18bed57a-e141-4de8-a38b-1f23815458c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge
• Version Model Number: 3.0
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899475002349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213977

FDA Product Code

• IYE: Accelerator, linear, 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: 2022-06-21
• Device Publish Date: 2022-06-10

On-Brand Devices [Edge]

• 00899475002349: 3.0
• 00858086006856: 4.1