ITE Transducer Arrays Large White Connector ITE1020WUS

GUDID 07290107984201

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290107984201
NIH Device Record Key2f2668ba-a8ba-459b-aadc-3eecc0c58e0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameITE Transducer Arrays Large White Connector
Version Model NumberITE1020W
Catalog NumberITE1020WUS
Company DUNS056552035
Company NameNOVOCURE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107984201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment
SDAElectrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290107984201]

Radiation Sterilization


[07290107984201]

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[07290107984201]

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[07290107984201]

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[07290107984201]

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[07290107984201]

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[07290107984201]

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[07290107984201]

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[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


[07290107984201]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-17
Device Publish Date2024-10-09

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07290107984201 - ITE Transducer Arrays Large White Connector2024-10-17
07290107984201 - ITE Transducer Arrays Large White Connector2024-10-17
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