Navigation Headrest Office

GUDID EFIAE0110081

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

Intersect ENT GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: EFIAE0110081
• NIH Device Record Key: 85cc238c-2c94-4284-9178-5a788a6edd9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Headrest Office
• Version Model Number: 1
• Company DUNS: 312623008
• Company Name: Intersect ENT GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com
• Phone: +13364282241
• Email: support@fiagon.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFIAE0110081 [Primary]

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: 2022-01-31
• Device Publish Date: 2022-01-22

Devices Manufactured by Intersect ENT GmbH

• 04260759931253 - VenSure Light Balloon Dilation System: 2022-10-24 Sinus Balloon Dilation system as set including Balloon dilation device, Inflation device, light-confirmation device
• EFIAE0030010 - Adhesive Pad: 2022-01-31
• EFIAE0110081 - Navigation Headrest Office: 2022-01-31The 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
• EFIAE0110081 - Navigation Headrest Office: 2022-01-31 The Navigation headrest is mounted on the procedurechairs instead It comprises a holder for a Navigatin sensor, which creates a
• EFIAE0135921 - Vensure Inflation Device: 2022-01-31 Inflation device for Vensure Balloon Dilation System
• EFIAE0111060 - Fiagon Navigation Unit: 2022-01-24 The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous p