Adhesive Pad E003001

GUDID 14260759930512

Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system.

Fiagon GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: 14260759930512
• NIH Device Record Key: ff16ba74-4826-454a-8b3c-f6a7d61ebea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adhesive Pad
• Version Model Number: E003001
• Catalog Number: E003001
• Company DUNS: 312623008
• Company Name: Fiagon GmbH
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260759930515 [Primary]
GS1	14260759930512 [Unit of Use]
HIBCC	EFIAE0030011 [Previous]

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: 2024-09-10
• Device Publish Date: 2024-09-02

Devices Manufactured by Fiagon GmbH

• 04260759930119 - RegistrationPointer: 2024-09-10 The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical pro
• 04260759930126 - VirtuEye: 2024-09-10 The device VirtuEye is a device for non-tactile registration for image guided surgical procedures. The device is accessory to t
• 04260759930256 - Navigation Headrest Universal: 2024-09-10 Headrest for navigation. Navigation sensor support for image guided surgery. The device is accessory to the Cube 4D Navigation s
• 04260759930362 - PointerShell 4 mm: 2024-09-10 The device PointerShell 4mm is an instrument tracker adapter for image guided surgery for instruments shafts of 3.5mm to 4mm. Th
• 04260759930379 - PointerShell 5 mm: 2024-09-10 The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. Th
• 04260759930386 - PointerShell 3 mm: 2024-09-10 The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm.
• 04260759930393 - PointerShell Universal: 2024-09-10 The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5
• 14260759930512 - Adhesive Pad: 2024-09-10Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation system.
• 14260759930512 - Adhesive Pad: 2024-09-10 Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation syst