| Primary Device ID | 07290107984447 |
| NIH Device Record Key | dd92e4ca-75bb-4876-becb-0e922962c394 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovoTAL flex |
| Version Model Number | SW000128 |
| Catalog Number | SW000128 |
| Company DUNS | 486647295 |
| Company Name | Novocure 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290107984447 [Primary] |
| NZK | Stimulator, Low Electric Field, Tumor Treatment |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 07290107986236 - Battery for Optune GIO | 2025-03-14 |
| 07290107986373 - Connection Cable for Optune Gio | 2025-03-14 Connection Cable unit |
| 07290107986380 - Battery for Optune GIO | 2025-03-14 |
| 07290107986397 - Optune Gio Battery Charger | 2025-03-14 |
| 07290107986403 - Power Supply for Optune Gio | 2025-03-14 |
| 07290107986427 - Optune Gio | 2025-03-14 |
| 07290107984447 - NovoTAL flex | 2024-11-13 |
| 07290107984447 - NovoTAL flex | 2024-11-13 |
| 17290107985892 - Optune HFE transducer array white | 2024-11-13 |