FDA.reportPublic FDA data

Device Bag for the Optune

Primary DI
07290107980029
Brand
Device Bag for the Optune
Company
NOVOCURE (ISRAEL) LTD
Model
BAG 9000_GRAY
Catalog number
90002
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

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
07290107980029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107980029072901079800297290107980029

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, Specify00Keep indoors
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
532457256
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107985215INE Transducer Arrays Tan Plaster and White ConnectorINE9TANWINE9020USW2021-02-04
07290107985208INE Transducer Arrays Tan Plaster and Black ConnectorINE9TANINE9020US2021-02-03
07290107980708INE Transducer Arrays White ConnectorINE9000WINE9000W2015-09-20
07290107980692INE Transducer Array Black ConnectorINE9000INE90002015-09-20
07290107980098Connection Cable for OptuneCAD9000900092015-09-20
07290107980197Portable Battery for OptuneIBH9000900192015-09-20
07290107980234Optune Porrtable Battery ChargerICH9000900232015-09-20
07290107980289Optune Porteable Battery RackPBR9000900392015-09-20
07290107980357Power Supply for OptuneSPS9000900462015-09-20
07290107980401OptuneTHF9000900512015-09-20

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