Device Bag for the Optune 90002

GUDID 07290107981569

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107981569
NIH Device Record Key5eb88f5a-3a6b-4ec8-a4c0-86b1d1d5ef9f
Commercial Distribution Discontinuation2019-04-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDevice Bag for the Optune
Version Model NumberBAG 9000_GRAY
Catalog Number90002
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107981569 [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 Number4
Public Version Date2019-04-24
Device Publish Date2015-09-20

Devices Manufactured by Novocure GmbH

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
07290107984300 - ILE Transducer Arrays Large White Connector2024-04-18

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