Navigation Sensor Flexarm N011012

GUDID 04260759930010

Field generating device, component of RIWOtrack Navigation System

Fiagon GmbH

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 04260759930010
• NIH Device Record Key: 8faebc98-5db0-45b8-96c8-87299072e96b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Sensor Flexarm
• Version Model Number: N011012
• Catalog Number: N011012
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260759930010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230700

FDA Product Code

• OLO: Orthopedic 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: 2024-01-15
• Device Publish Date: 2024-01-05

Devices Manufactured by Fiagon GmbH

• 04260759930010 - Navigation Sensor Flexarm: 2024-01-15Field generating device, component of RIWOtrack Navigation System
• 04260759930010 - Navigation Sensor Flexarm: 2024-01-15 Field generating device, component of RIWOtrack Navigation System
• 04260759930027 - Localizer K-Wire: 2024-01-15 Patient referencing device, component of RIWOtrack Navigation System
• 04260759930034 - MapperBridge: 2024-01-15 Patient registration device, component of RIWOtrack Navigation System
• 04260759930041 - MultiPad: 2024-01-15 Tool registration device, component of RIWOtrack Navigation System
• 04260759930058 - RIWOtrack Cube4D: 2024-01-15 Navigation unit, Component of RIWOtrack Navigation System
• 04260759930072 - Adapter for Flexsensor: 2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Flexsensor, component of RIWOtrack Navigation System
• 04260759930089 - Adapter for Clipsensor: 2024-01-15 Adapter for navigation probe, to be used with RIWOtrack Clipsensor, component of RIWOtrack Navigation System
• 04260759930096 - RIWOtrack Flexsensor: 2024-01-15 Navigation probe, component of RIWOtrack Navigation System