Power Supply for Optune 90046

GUDID 07290107981675

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107981675
NIH Device Record Key3aff8dd6-da14-431f-ac7a-b1a73156de62
Commercial Distribution Discontinuation2019-04-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePower Supply for Optune
Version Model NumberSPS9000
Catalog Number90046
Company DUNS056552035
Company NameNOVOCURE INC.
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

Special Storage Condition, SpecifyBetween 0 and 0 *Keep indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep indoors
Special Storage Condition, SpecifyBetween 0 and 0 *Keep indoors

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107981675 [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

On-Brand Devices [Power Supply for Optune]

07290107981767SPS9100
07290107981675SPS9000

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