VenSure Light Balloon Dilation System E 01 3536

GUDID 04260759931253

Sinus Balloon Dilation system as set including Balloon dilation device, Inflation device, light-confirmation device

Intersect ENT GmbH

Nasal/paranasal balloon catheter

• Primary Device ID: 04260759931253
• NIH Device Record Key: d91f7bf7-b4be-432e-a734-53e58876294f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenSure Light Balloon Dilation System
• Version Model Number: 1
• Catalog Number: E 01 3536
• Company DUNS: 312623008
• Company Name: Intersect ENT 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	04260759931253 [Primary]
GS1	04260759932250 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	14260759931250 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• LCR: Fluorescent Immunoassay, Tobramycin
• 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: 2022-10-24
• Device Publish Date: 2022-10-14

Devices Manufactured by Intersect ENT GmbH

• 04260759931253 - VenSure Light Balloon Dilation System: 2022-10-24Sinus Balloon Dilation system as set including Balloon dilation device, Inflation device, light-confirmation device
• 04260759931253 - VenSure Light Balloon Dilation System: 2022-10-24 Sinus Balloon Dilation system as set including Balloon dilation device, Inflation device, light-confirmation device
• EFIAE0030010 - Adhesive Pad: 2022-01-31
• EFIAE0110081 - Navigation Headrest Office: 2022-01-31 The Navigation headrest is mounted on the procedurechairs instead It comprises a holder for a Navigatin sensor, which creates a
• EFIAE0135921 - Vensure Inflation Device: 2022-01-31 Inflation device for Vensure Balloon Dilation System
• EFIAE0111060 - Fiagon Navigation Unit: 2022-01-24 The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous p