VirtuEye E 01 1430

GUDID EFIAE0114301

Accessory to Cube navigation systems. Device for registration.

Fiagon GmbH

ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system ENT stereotactic surgery system 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

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• 04260759930072 - Adapter for Flexsensor: 2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Flexsensor, component of RIWOtrack Navigation System
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• 04260759930096 - RIWOtrack Flexsensor: 2024-01-15 Navigation probe, component of RIWOtrack Navigation System