MAXPOINT BR-I SW000060

GUDID 07290107983136

Transducer Array Layout Planning software

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107983136
NIH Device Record Key60ab74a4-2098-4c83-9702-5d2a805ec0d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAXPOINT BR-I
Version Model Number1.1.0
Catalog NumberSW000060
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 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
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107983136 [Primary]

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 Date2024-08-16
Device Publish Date2024-08-08

Devices Manufactured by Novocure GmbH

07290107983136 - MAXPOINT BR-I 2024-08-16Transducer Array Layout Planning software
07290107983136 - MAXPOINT BR-I 2024-08-16 Transducer Array Layout Planning software
07290107982689 - NovoTAL Software for Array Mapping2024-04-18
07290107983266 - Battery for Optune GIO2024-04-18
07290107983273 - Battery for Optune GIO2024-04-18
07290107983280 - Battery for Optune GIO2024-04-18
07290107984270 - ILE Transducer Arrays Small Black Connector2024-04-18
07290107984287 - ILE Transducer Arrays Small White Connector2024-04-18
07290107984294 - ILE Transducer Arrays Large White Connector2024-04-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.