Navigation Unit Cube4D

Basic Information

• Brand Name: Navigation Unit Cube4D
• Primary DI: 04260759930133
• Version / Model: E011106-HD/8
• Catalog Number: E011106-HD/8
• Company Name: Fiagon GmbH
• Labeler DUNS: 312623008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-16
• Public Version: 1
• Public Version Date: 2025-01-24
• Public Version Status: New
• Public Device Record Key: 86d7b2c5-4512-43bc-89e3-876a11a8fee6

Device Description

Navigation unit, Component of Cube4D Navigation System

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: MR Unsafe
• 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
45199	Multi-purpose stereotactic surgery system	An electrically-powered 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 a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. 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	04260759930133	GS1
Previous	EFIAE0111060	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K211291	000