Optune Porteable Battery Rack 90039

GUDID 07290107981514

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107981514
NIH Device Record Key23392366-1e4f-4d53-aa16-eb65e0959448
Commercial Distribution Discontinuation2019-04-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOptune Porteable Battery Rack
Version Model NumberPBR9000
Catalog Number90039
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107981514 [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

07290107983310 - INE Transducer Arrays Tan Plaster and Black Connector2021-02-10
07290107982764 - ILE Transducer Arrays Small White Connector2020-12-17
07290107982771 - ILE Transducer Arrays Large White Connector2020-12-17
07290107982788 - ILE Transducer Arrays Large White Connector2020-12-17
07290107982801 - Power Supply for NovoTTF-100L 2020-12-17
07290107982757 - ILE Transducer Arrays Small Black Connector2020-12-16
07290107982917 - Portable Battery for NovoTTF-100L2020-12-16
07290107982948 - Connection Cable for NovoTTF-100L2020-12-16

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