INE Transducer Array Black Connector INE9000

GUDID 07290107980692

NOVOCURE (ISRAEL) LTD

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290107980692
NIH Device Record Keyd5a81a2a-5031-4c53-9541-5a4b2908b8c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameINE Transducer Array Black Connector
Version Model NumberINE9000
Catalog NumberINE9000
Company DUNS532457256
Company NameNOVOCURE (ISRAEL) LTD
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290000000002 [Primary]
GS107290107980692 [Package]
Contains: 07290107983358
Package: Carton Box [20 Units]
In Commercial Distribution
GS107290107983358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290107980692]

Radiation Sterilization


Device Entry Metadata

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

Devices Manufactured by NOVOCURE (ISRAEL) LTD

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07290107982740 - Power Supply for NovoTTF-100L 2020-12-17
07290107982849 - ILE Transducer Arrays Large White Connector2020-12-17
07290107982870 - Portable Battery for NovoTTF-100L2020-12-16
07290107982900 - Connection Cable for NovoTTF-100L2020-12-16
07290107982733 - NovoTTF-100L2020-12-15

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