85f199cf-2ab0-4977-8cd0-1f1c703a6815UpdatePublished42019-04-242015-09-202019-04-23Not in Commercial Distribution07290107981538PrimaryGS1OptuneTHF900090051486647295Novocure GmbH1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-855-281-9301support@novocure.comP100034001P100034002P100034003P100034004P100034005P100034006P100034007P100034008P100034009P100034010P100034011P10003401258847Alternating electric field antimitotic cancer treatment system generatorA portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable.falseActiveNZKStimulator, Low Electric Field, Tumor TreatmentSpecial Storage Condition, SpecifyWEEESpecial Storage Condition, SpecifyKeep drySpecial Storage Condition, SpecifyFragile - handle with careSpecial Storage Condition, SpecifyKeep away from extreme heat and sources of radiationStorage Environment HumidityStorage Environment Temperaturefalsefalse