VenSure 4D Balloon Dilation System E 01 3566

GUDID 04260759931680

Balloon Dilation system as a set including navigated Balloon dilation device with bending tool and inflation device tubes.

Fiagon GmbH

Nasal/paranasal balloon catheter

• Primary Device ID: 04260759931680
• NIH Device Record Key: ec1768c7-df64-4ce0-a16d-321f9cfcad52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenSure 4D Balloon Dilation System
• Version Model Number: 1
• Catalog Number: E 01 3566
• Company DUNS: 312623008
• Company Name: Fiagon GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	04260759931673 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	04260759931680 [Primary]

FDA Product Code

• LRC: Instrument, Ent Manual Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-26
• Device Publish Date: 2025-09-18

Devices Manufactured by Fiagon GmbH

• 04260759931680 - VenSure 4D Balloon Dilation System: 2025-09-26Balloon Dilation system as a set including navigated Balloon dilation device with bending tool and inflation device tubes.
• 04260759931680 - VenSure 4D Balloon Dilation System: 2025-09-26 Balloon Dilation system as a set including navigated Balloon dilation device with bending tool and inflation device tubes.
• 04260759930003 - Integrated Headrest: 2025-07-03 The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an elec
• 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.