RegistrationPointer E012003

GUDID 04260759930119

The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system.

Fiagon GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: 04260759930119
• NIH Device Record Key: 65fc966a-8765-4a40-b2c0-2fc8fa6574aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RegistrationPointer
• Version Model Number: E012003
• Catalog Number: E012003
• Company DUNS: 312623008
• Company Name: Fiagon 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: true
• 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	04260759930119 [Primary]
HIBCC	EFIAE0120031 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141456

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

On-Brand Devices [RegistrationPointer]

• EFIAE0120031: The products RegistrationPointer is a navigated pointer probe for performing non-steril registra
• 04260759930119: The device RegistrationPointer is a navigated pointer probe for performing non-steril registrati