| Primary Device ID | 07290107982078 |
| NIH Device Record Key | b67e265e-03f0-4c63-99f1-78ff3c5ed58b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Device Bag for Optune |
| Version Model Number | BAG9100 |
| Catalog Number | BAG9100US |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-281-9301 |
| support@novocure.com |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290107982078 [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 | 2018-09-05 |
| Device Publish Date | 2018-08-05 |
| 07290107984447 - NovoTAL flex | 2024-11-13 |
| 17290107985892 - Optune HFE transducer array white | 2024-11-13 |
| 07290107985888 - Optune HFE transducer array black | 2024-11-13 |
| 07290107983006 - Optune Lua Connection Cable | 2024-10-18 |
| 07290107983037 - Battery for Optune Lua | 2024-10-18 |
| 07290107983068 - Battery Charger for Optune Lua | 2024-10-18 |
| 07290107983099 - Optune Lua Power Supply | 2024-10-18 |
| 07290107983129 - Optune Lua (NovoTTF-200T) | 2024-10-18 |