VenSure Balloon Dilation System E 01 3526

GUDID 04260759932243

Sinus Balloon Dilation system as set including Balloon dilation device with bending tool and Inflation device with tubes,

Fiagon GmbH

Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter

• Primary Device ID: 04260759932243
• NIH Device Record Key: f48de5d9-76f2-4c51-925f-94e855b144f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenSure Balloon Dilation System
• Version Model Number: 1
• Catalog Number: E 01 3526
• 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	04260759931246 [Primary]
GS1	04260759932243 [Package]; Contains: 04260759931246; Package: [5 Units]; In Commercial Distribution
GS1	14260759931243 [Package]; Contains: 04260759931246; Package: [5 Units]; In Commercial Distribution

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: 2022-11-18
• Device Publish Date: 2022-11-10

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