INE Transducer Array Black Connector INE9000

GUDID 07290107981545

Novocure GmbH

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290107981545
NIH Device Record Key2f13aae0-6cca-4088-825f-587db2906e2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameINE Transducer Array Black Connector
Version Model NumberINE9000
Catalog NumberINE9000
Company DUNS486647295
Company NameNovocure GmbH
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100729000000006 [Primary]
GS107290107981545 [Package]
Contains: 07290107983334
Package: Carton Box [20 Units]
In Commercial Distribution
GS107290107983334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290107981545]

Radiation Sterilization


[07290107981545]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-13
Device Publish Date2015-09-20

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07290107983099 - Optune Lua Power Supply2024-10-18
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