Navigation Headrest Office

Basic Information

• Brand Name: Navigation Headrest Office
• Primary DI: EFIAE0110081
• Version / Model: 1
• Company Name: Fiagon GmbH
• Labeler DUNS: 312623008
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-22
• Public Version: 3
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 85cc238c-2c94-4284-9178-5a788a6edd9b

Device Description

The Navigation headrest is mounted on the procedurechairs instead It comprises a holder for a Navigatin sensor, which creates an electromagnetic field above the cushion of the Navigation headrest. The navigation headrest Office comes with the following adapters: 1) Chair Adapter A 2) Chair Adapter B 3) Chair Adapter C 4) Chair Adapter D 5) Chair Adapter E 6) Chair Adapter F 7) Chair Adapter R

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: No
• 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	EFIAE0110081	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]