Device Bag for Optune BAG9100US

GUDID 07290107982078

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107982078
NIH Device Record Keyb67e265e-03f0-4c63-99f1-78ff3c5ed58b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDevice Bag for Optune
Version Model NumberBAG9100
Catalog NumberBAG9100US
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
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107982078 [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 Date2018-09-05
Device Publish Date2018-08-05

Devices Manufactured by Novocure GmbH

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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

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