FDA.reportPublic FDA data

INE Transducer Array Black Connector

Primary DI
07290107983358
Brand
INE Transducer Array Black Connector
Company
Novocure GmbH
Model
INE9000
Catalog number
INE9000
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
P100034011
P100034012

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
P100034011NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P100034012NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107980692PackageGS120Not in Commercial Distribution
07290107983358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107980692072901079806927290107980692
07290107983358072901079833587290107983358

GMDN Terms#

Term, Definition table
TermDefinition
Alternating electric field antimitotic cancer treatment system transducer arrayA sterile, disposable, head-worn component of an alternating electric field cancer treatment system designed to convert intermediate-frequency (100-300 kHz) alternating electric current to low-intensity alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Otherwise known as insulated field inducing electrodes (INE), the device is connected to an alternating current generator and consists of an array of ceramic discs contained in a plastic membrane, and is intended to be worn continuously for a period of 3-4 days before disposal. This is single-use device.

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 Humidity35 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
486647295
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
07290107986427Optune Gio Novocure 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