FDA.reportPublic FDA data

Optune Gio

Primary DI
07290107986427
Brand
Optune Gio
Company
Novocure GmbH
Model
TFH9100
Catalog number
TFH9100US
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZKStimulator, Low Electric Field, Tumor Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZKStimulator, Low Electric Field, Tumor TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100034001
P100034002
P100034003
P100034004
P100034005
P100034006
P100034007
P100034008
P100034009
P100034010
P100034012
P100034013
P100034014
P100034015
P100034016
P100034017
P100034018
P100034019
P100034020
P100034021
P100034022
P100034023
P100034031
P100034032
P100034033
P100034034
P100034035
P100034036

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100034001NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034002NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034003NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034004NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034005NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034006NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034007NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034008NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034009NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034010NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034012NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034013NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034014NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034015NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034016NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034017NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034018NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034019NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034020NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034021NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034022NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034023NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034031NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034032NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034033NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034034NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034035NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034036NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107986427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107986427072901079864277290107986427

GMDN Terms#

Term, Definition table
TermDefinition
Alternating 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile - handle with care
Special Storage Condition, Specify00Keep away from extreme heat and sources of radiation
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00WEEE
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-281-9301support@novocure.com

Regulatory Flags#

DUNS number
486647295
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107984072ITE Transducer Arrays Small Black ConnectorITE1013BITE1013BUS2024-10-09
07290107984188ITE Transducer Arrays Small White ConnectorITE1013WITE1013WUS2024-10-09
07290107984195ITE Transducer Arrays Large Black ConnectorITE1020BITE1020BUS2024-10-09
07290107984201ITE Transducer Arrays Large White ConnectorITE1020WITE1020WUS2024-10-09
07290107987462Connection Cable for Optune PaxCAD9100CAD204US2026-02-16
07290107987479Battery for Optune PaxIBH9200IBH9204US2026-02-16
07290107987486Optune Pax Battery ChargerICH9100ICH9204US2026-02-16
07290107987493Power Supply for Optune Pax SPS9200SPS92004US2026-02-16
07290107987509Optune PaxTFP9200TFP9200US 2026-02-16
07290107985352ITE Transducer Arrays Small Black ConnectorITE1013BITE1013BUS2024-10-09
07290107985369ITE Transducer Arrays Small White ConnectorITE1013WITE1013WUS2024-10-09
07290107985376ITE Transducer Arrays Large Black ConnectorITE1020BITE1020BUS2024-10-09
07290107985383ITE Transducer Arrays Large White ConnectorITE1020WITE1020WUS2024-10-09
07290107985895Optune HFE transducer array white IHEP9020WIHEP9020WUS2024-11-05
07290107985888Optune HFE transducer array black IHEP9020BIHEP9020BUS2024-11-05
07290107984294ILE Transducer Arrays Large Black ConnectorILE1030ILE1030US2024-04-10
07290107986236Battery for Optune GIOIBH9100IBH9103US2025-03-06
07290107986373Connection Cable for Optune GioCAD9100CAD9100US2025-03-06
07290107986380Battery for Optune GIOIBH9100IBH9100US2025-03-06
07290107986397Optune Gio Battery ChargerICH9100ICH9100US2025-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107986236Battery for Optune GIONovocure GmbHNZK2025-03-06
07290107986373Connection Cable for Optune GioNovocure GmbHNZK2025-03-06
07290107986380Battery for Optune GIONovocure GmbHNZK2025-03-06
07290107986397Optune Gio Battery ChargerNovocure GmbHNZK2025-03-06
07290107986403Power Supply for Optune GioNovocure GmbHNZK2025-03-06
07290107985895Optune HFE transducer array white Novocure GmbHNZK2024-11-05
07290107984447NovoTAL flex Novocure GmbHNZK2024-11-05
17290107985892Optune HFE transducer array white Novocure GmbHNZK2024-11-05
07290107985888Optune HFE transducer array black Novocure GmbHNZK2024-11-05
07290107983136MAXPOINT BR-I Novocure GmbHNZK2024-08-08
07290107982689NovoTAL Software for Array MappingNovocure GmbHNZK2024-04-10
07290107983266Battery for OptuneNovocure GmbHNZK2024-04-10
07290107983273Battery for Optune GIONovocure GmbHNZK2024-04-10
07290107983280Battery for Optune Novocure GmbHNZK2024-04-10
07290107985185INE Transducer Arrays Tan Plaster and Black ConnectorFLEXTRONICS ROMANIA SRLNZK2021-02-09
07290107983839INE Transducer Arrays Tan Plaster and Black ConnectorNovocure GmbHNZK2021-02-09
07290107983303INE Transducer Arrays Tan Plaster and White ConnectorNovocure GmbHNZK2021-02-04
07290107983327INE Transducer Arrays Tan Plaster and White ConnectorNovocure GmbHNZK2021-02-04
07290107983846INE Transducer Arrays Tan Plaster and White ConnectorNovocure GmbHNZK2021-02-04
07290107985109INE Transducer Arrays Tan Plaster and White ConnectorNovocure GmbHNZK2021-02-04
07290107985192INE Transducer Arrays Tan Plaster and White ConnectorFLEXTRONICS ROMANIA SRLNZK2021-02-04
07290107985215INE Transducer Arrays Tan Plaster and White ConnectorNOVOCURE (ISRAEL) LTDNZK2021-02-04
07290107985093INE Transducer Arrays Tan Plaster and Black ConnectorNovocure GmbHNZK2021-02-03
07290107985208INE Transducer Arrays Tan Plaster and Black ConnectorNOVOCURE (ISRAEL) LTDNZK2021-02-03
07290107982610INE Transducer Arrays Tan Plaster and White ConnectorNovocure GmbHNZK2020-12-21
07290107985178INE Transducer Arrays Tan Plaster and White ConnectorINTEGRA BIOTECHNICAL LLCNZK2020-12-21
07290107982603INE Transducer Arrays Tan Plaster and Black ConnectorNovocure GmbHNZK2020-12-11
07290107983297INE Transducer Arrays Tan Plaster and Black ConnectorNovocure GmbHNZK2020-08-19
07290107983310INE Transducer Arrays Tan Plaster and Black ConnectorNovocure GmbHNZK2020-08-19
07290107984881INE Transducer Arrays Tan Plaster and Black ConnectorNOVOCURE INC.NZK2020-08-19