NovoTAL Software for Array Mapping 90094

GUDID 07290107981729

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107981729
NIH Device Record Key85e432c4-f56a-4764-8996-ea7ba78a30bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoTAL Software for Array Mapping
Version Model NumberNovoTAL Software
Catalog Number90094
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107981729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-20

Devices Manufactured by NOVOCURE INC.

07290107983297 - INE Transducer Arrays Tan Plaster and Black Connector2021-02-10
07290107982825 - ILE Transducer Arrays Small White Connector2020-12-17
07290107982832 - ILE Transducer Arrays Large White Connector2020-12-17
07290107982863 - Power Supply for NovoTTF-100L 2020-12-17
07290107982818 - ILE Transducer Arrays Small Black Connector2020-12-16
07290107982955 - Portable Battery for NovoTTF-100L2020-12-16
07290107982986 - Connection Cable for NovoTTF-100L2020-12-16
07290107982856 - NovoTTF-100L2020-12-15

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