NovoTAL flex SW000128

GUDID 07290107984447

Novocure GmbH

Alternating electric field antimitotic cancer treatment system
Primary Device ID07290107984447
NIH Device Record Keydd92e4ca-75bb-4876-becb-0e922962c394
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoTAL flex
Version Model NumberSW000128
Catalog NumberSW000128
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107984447 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-13
Device Publish Date2024-11-05

Devices Manufactured by Novocure GmbH

07290107984447 - NovoTAL flex 2024-11-13
07290107984447 - NovoTAL flex 2024-11-13
17290107985892 - Optune HFE transducer array white 2024-11-13
07290107985888 - Optune HFE transducer array black 2024-11-13
07290107983006 - Optune Lua Connection Cable2024-10-18
07290107983037 - Battery for Optune Lua2024-10-18
07290107983068 - Battery Charger for Optune Lua2024-10-18
07290107983099 - Optune Lua Power Supply2024-10-18
07290107983129 - Optune Lua (NovoTTF-200T)2024-10-18

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