VirtuEye

Basic Information

• Brand Name: VirtuEye
• Primary DI: EFIAE0114301
• Version / Model: v2
• Catalog Number: E 01 1430
• Company Name: Fiagon GmbH
• Labeler DUNS: 312623008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-10
• Public Version: 3
• Public Version Date: 2022-10-25
• Public Version Status: Update
• Public Device Record Key: 1880c865-60c5-4a6d-88d7-fa7607c14966

Device Description

Accessory to Cube navigation systems. Device for registration.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45198	ENT stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during ear/nose/throat (ENT) surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EFIAE0114301	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K211291	000