RIWOtrack Flexsensor N012950

GUDID 04260759930096

Navigation probe, component of RIWOtrack Navigation System

Fiagon GmbH

Multi-purpose stereotactic surgery system

• Primary Device ID: 04260759930096
• NIH Device Record Key: 4ace60e6-1a3f-4264-a242-9889b689cfbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIWOtrack Flexsensor
• Version Model Number: N012950
• Catalog Number: N012950
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260759930096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230700

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

[04260759930096]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-15
• Device Publish Date: 2024-01-05

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: 2024-09-10 Adhesive pads for fixation of patient localizer for image guided surgery. The device is accessory to the Cube 4D Navigation syst