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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 07290107986427 [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 | 2025-03-14 |
Device Publish Date | 2025-03-06 |
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 |
17290107985892 - Optune HFE transducer array white | 2024-11-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OPTUNE GIO 97566122 not registered Live/Pending |
Novocure GmbH 2022-08-26 |