| Primary Device ID | 07290107981545 |
| NIH Device Record Key | 2f13aae0-6cca-4088-825f-587db2906e2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INE Transducer Array Black Connector |
| Version Model Number | INE9000 |
| Catalog Number | INE9000 |
| 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 | 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 |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *WEEE |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile - handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from extreme heat and sources of radiation |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00729000000006 [Primary] |
| GS1 | 07290107981545 [Package] Contains: 07290107983334 Package: Carton Box [20 Units] In Commercial Distribution |
| GS1 | 07290107983334 [Primary] |
| NZK | Stimulator, Low Electric Field, Tumor Treatment |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
[07290107981545]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-13 |
| Device Publish Date | 2015-09-20 |
| 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 |
| 17290107985892 - Optune HFE transducer array white | 2024-11-13 |