FDA.reportPublic FDA data

ITE Transducer Arrays Small Black Connector

Primary DI
07290107985352
Brand
ITE Transducer Arrays Small Black Connector
Company
Novocure GmbH
Model
ITE1013B
Catalog number
ITE1013BUS
Published
2024-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGZElectrical Tumor Treatment Fields
SDAElectrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
SHCLow Electric Field Generator For Pancreatic Cancer Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGZElectrical Tumor Treatment FieldsUnknown3
SDAElectrical Tumor Treatment Fields For Non-Small Cell Lung CancerUnknown3
SHCLow Electric Field Generator For Pancreatic Cancer TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H180002001
H180002003
P100034000
P230042000
P250034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H180002001
H180002003
P100034000NOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbH2011-04-08NZK
P230042000Optune LuaNovocure, GmbH2024-10-15SDA
P250034000Optune PaxNovocure, GmbH2026-02-11SHC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290107985359PackageGS120In Commercial Distribution
27290107985356PackageGS15In Commercial Distribution
37290107985353PackageGS115In Commercial Distribution
07290107985352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010798535917290107985359
2729010798535627290107985356
3729010798535337290107985353
07290107985352072901079853527290107985352

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
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius27 Degrees Celsius
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 Temperature0 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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107983266Battery for OptuneIBH9100IBH9100US2024-04-10
07290107983280Battery for OptuneIBH9100IBH9100US2024-04-10
07290107981606Optune Battery ChargerICH9100ICH9100US2018-08-05
07290107981613Power Supply for OptuneSPS9100SPS9100US2018-08-05
07290107981750Optune Battery ChargerICH9100ICH9100US2018-08-05
07290107981767Power Supply for OptuneSPS9100SPS9100US2018-08-05
07290107982030Power Supply for OptuneSPS9100SPS9100US2018-08-05
07290107982047Optune Battery ChargerICH9100ICH9100US2018-08-05
07290107982207OptuneTFH9100TFH9100US2018-08-05
07290107982214OptuneTFH9100TFH9100US2018-08-05
07290107982221OptuneTFH9100TFH9100US2018-08-05
07290107982474Connection Cable for OptuneCAD9100CAD9100US2018-08-05
07290107982481Connection Cable for OptuneCAD9100CAD9100US2018-08-01
07290107982498Connection Cable for OptuneCAD9100CAD9100US2018-08-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107987462Connection Cable for Optune PaxNovocure GmbHSHC2026-02-16
07290107987479Battery for Optune PaxNovocure GmbHSHC2026-02-16
07290107987486Optune Pax Battery ChargerNovocure GmbHSHC2026-02-16
07290107987493Power Supply for Optune Pax Novocure GmbHSHC2026-02-16
07290107987509Optune PaxNovocure GmbHSHC2026-02-16
07290107984072ITE Transducer Arrays Small Black ConnectorNovocure GmbHSDA2024-10-09
07290107984072ITE Transducer Arrays Small Black ConnectorNovocure GmbHQGZ2024-10-09
07290107984188ITE Transducer Arrays Small White ConnectorNovocure GmbHQGZ2024-10-09
07290107984188ITE Transducer Arrays Small White ConnectorNovocure GmbHSDA2024-10-09
07290107984195ITE Transducer Arrays Large Black ConnectorNovocure GmbHQGZ2024-10-09
07290107984195ITE Transducer Arrays Large Black ConnectorNovocure GmbHSDA2024-10-09
07290107984201ITE Transducer Arrays Large White ConnectorNovocure GmbHQGZ2024-10-09
07290107984201ITE Transducer Arrays Large White ConnectorNovocure GmbHSDA2024-10-09
07290107985369ITE Transducer Arrays Small White ConnectorNovocure GmbHQGZ2024-10-09
07290107985369ITE Transducer Arrays Small White ConnectorNovocure GmbHSDA2024-10-09
07290107985369ITE Transducer Arrays Small White ConnectorNovocure GmbHSHC2024-10-09
07290107985376ITE Transducer Arrays Large Black ConnectorNovocure GmbHSHC2024-10-09
07290107985376ITE Transducer Arrays Large Black ConnectorNovocure GmbHSDA2024-10-09
07290107985376ITE Transducer Arrays Large Black ConnectorNovocure GmbHQGZ2024-10-09
07290107985383ITE Transducer Arrays Large White ConnectorNovocure GmbHQGZ2024-10-09
07290107985383ITE Transducer Arrays Large White ConnectorNovocure GmbHSDA2024-10-09
07290107985383ITE Transducer Arrays Large White ConnectorNovocure GmbHSHC2024-10-09
07290107984270ILE Transducer Arrays Small Black ConnectorNovocure GmbHQGZ2024-04-10
07290107984270ILE Transducer Arrays Small Black ConnectorNovocure GmbHSDA2024-04-10
07290107984287ILE Transducer Arrays Small White ConnectorNovocure GmbHQGZ2024-04-10
07290107984287ILE Transducer Arrays Small White ConnectorNovocure GmbHSDA2024-04-10
07290107984294ILE Transducer Arrays Large Black ConnectorNovocure GmbHQGZ2024-04-10
07290107984294ILE Transducer Arrays Large Black ConnectorNovocure GmbHSDA2024-04-10
07290107984300ILE Transducer Arrays Large White ConnectorNovocure GmbHQGZ2024-04-10
07290107984300ILE Transducer Arrays Large White ConnectorNovocure GmbHSDA2024-04-10