VirtuEye E 01 1430

GUDID EFIAE0114301

Accessory to Cube navigation systems. Device for registration.

Fiagon GmbH

ENT stereotactic surgery system

• Primary Device ID: EFIAE0114301
• NIH Device Record Key: 1880c865-60c5-4a6d-88d7-fa7607c14966
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VirtuEye
• Version Model Number: v2
• Catalog Number: E 01 1430
• Company DUNS: 312623008
• Company Name: Fiagon GmbH
• 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
HIBCC	EFIAE0114301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211291

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

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: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [VirtuEye]

• EFIAE0114301: Accessory to Cube navigation systems. Device for registration.
• 04260759930126: The device VirtuEye is a device for non-tactile registration for image guided surgical procedure