EDGE Radiosurgery System

GUDID 00899475002257

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system

• Primary Device ID: 00899475002257
• NIH Device Record Key: a2005e22-e7fb-4e1c-b83d-f0e1b2a149de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGE Radiosurgery System
• Version Model Number: 2.7
• 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	00899475002257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171733

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: 2019-04-29
• Device Publish Date: 2019-04-19

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