FDA.reportPublic FDA data

ITE Transducer Arrays Large Black Connector

Primary DI
07290107984195
Brand
ITE Transducer Arrays Large Black Connector
Company
Novocure GmbH
Model
ITE1020B
Catalog number
ITE1020BUS
Published
2024-10-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
07290107984195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107984195072901079841957290107984195

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
Handling Environment Humidity00
Handling Environment Temperature00
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 Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
486647295
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
07290107986403Power Supply for Optune GioSPS9100SPS9100US2025-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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 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
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 GmbHSDA2024-04-10
07290107984294ILE Transducer Arrays Large Black ConnectorNovocure GmbHQGZ2024-04-10
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 GmbHSDA2022-09-18
07290107983099Optune Lua Power SupplyNovocure GmbHQGZ2022-09-18
07290107983129Optune Lua (NovoTTF-200T)Novocure GmbHQGZ2022-09-18
07290107983129Optune Lua (NovoTTF-200T)Novocure GmbHSDA2022-09-18
07290107983143Optune Lua Connection CableNovocure GmbHQGZ2022-09-18
07290107983143Optune Lua Connection CableNovocure GmbHSDA2022-09-18