FDA.reportPublic FDA data

ITE Transducer Arrays Small Black Connector

Primary DI
07290107984072
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGZElectrical Tumor Treatment FieldsUnknown3
SDAElectrical Tumor Treatment Fields For Non-Small Cell Lung CancerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H180002001
H180002003
P230042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H180002001
H180002003
P230042000Optune LuaNovocure, GmbH2024-10-15SDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107984072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107984072072901079840727290107984072

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
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
07290107984188ITE Transducer Arrays Small White ConnectorITE1013WITE1013WUS2024-10-09
07290107984195ITE Transducer Arrays Large Black ConnectorITE1020BITE1020BUS2024-10-09
07290107984201ITE Transducer Arrays Large White ConnectorITE1020WITE1020WUS2024-10-09
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
07290107986403Power Supply for Optune GioSPS9100SPS9100US2025-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107984188ITE Transducer Arrays Small White ConnectorNovocure GmbHQGZ2024-10-09
07290107984188ITE Transducer Arrays Small White ConnectorNovocure GmbHSDA2024-10-09
07290107984195ITE Transducer Arrays Large Black ConnectorNovocure GmbHSDA2024-10-09
07290107984195ITE Transducer Arrays Large Black ConnectorNovocure GmbHQGZ2024-10-09
07290107984201ITE Transducer Arrays Large White ConnectorNovocure GmbHQGZ2024-10-09
07290107984201ITE Transducer Arrays Large White ConnectorNovocure GmbHSDA2024-10-09
07290107985352ITE Transducer Arrays Small Black ConnectorNovocure GmbHSDA2024-10-09
07290107985352ITE Transducer Arrays Small Black ConnectorNovocure GmbHQGZ2024-10-09
07290107985369ITE Transducer Arrays Small White ConnectorNovocure GmbHSDA2024-10-09
07290107985369ITE Transducer Arrays Small White ConnectorNovocure GmbHQGZ2024-10-09
07290107985376ITE Transducer Arrays Large Black ConnectorNovocure GmbHQGZ2024-10-09
07290107985376ITE Transducer Arrays Large Black ConnectorNovocure GmbHSDA2024-10-09
07290107985383ITE Transducer Arrays Large White ConnectorNovocure GmbHQGZ2024-10-09
07290107985383ITE Transducer Arrays Large White ConnectorNovocure GmbHSDA2024-10-09
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
07290107983006Optune Lua Connection CableNovocure GmbHQGZ2022-09-18
07290107983006Optune Lua Connection CableNovocure GmbHSDA2022-09-18
07290107983099Optune Lua Power SupplyNovocure GmbHQGZ2022-09-18
07290107983099Optune Lua Power SupplyNovocure GmbHSDA2022-09-18
07290107983129Optune Lua (NovoTTF-200T)Novocure GmbHSDA2022-09-18
07290107983129Optune Lua (NovoTTF-200T)Novocure GmbHQGZ2022-09-18
07290107983143Optune Lua Connection CableNovocure GmbHSDA2022-09-18
07290107983143Optune Lua Connection CableNovocure GmbHQGZ2022-09-18