| 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 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 |
| LCR | Fluorescent Immunoassay, Tobramycin |
| LRC | Instrument, Ent Manual Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-24 |
| Device Publish Date | 2022-10-14 |
| 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 |