RIWOtrack Cube4D E011106-HD/8 RW

GUDID 04260759931567

Navigation unit, 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: 04260759931567
• NIH Device Record Key: 942af497-9ce6-44f8-96ef-894e982e1b75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIWOtrack Cube4D
• Version Model Number: E011106-HD/8 RW
• Catalog Number: E011106-HD/8 RW
• 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	04260759931567 [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

On-Brand Devices [RIWOtrack Cube4D]

• 04260759931567: Navigation unit, Component of RIWOtrack Navigation System
• 04260759930058: Navigation unit, Component of RIWOtrack Navigation System