| 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 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 |
| 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 | 2022-11-18 |
| Device Publish Date | 2022-11-10 |
| 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. |