Optune Gio TFH9100US
GUDID 07290107986427
Novocure GmbH
Alternating electric field antimitotic cancer treatment system generator| Primary Device ID | 07290107986427 |
| NIH Device Record Key | 85fd2dc2-40e1-48e1-a479-75765bf60ae3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optune Gio |
| Version Model Number | TFH9100 |
| Catalog Number | TFH9100US |
| 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 | 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 |
Customer Support Contacts
| 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 | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com | |
| Phone | 1-855-281-9301 |
| support@novocure.com |
Operating and Storage Conditions
| 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 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 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290107986427 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P100034
FDA Product Code
| NZK | Stimulator, Low Electric Field, Tumor Treatment |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-14 |
| Device Publish Date | 2025-03-06 |
Devices Manufactured by Novocure GmbH
| 07290107985895 - Optune HFE transducer array white | 2025-06-26 |
| 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 |
| 07290107986427 - Optune Gio | 2025-03-14 |
| 07290107984447 - NovoTAL flex | 2024-11-13 |
Trademark Results [Optune Gio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTUNE GIO 97566122 not registered Live/Pending |
Novocure GmbH 2022-08-26 |
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