INE Transducer Arrays White Connector INE9000W

GUDID 07290000000003

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290000000003
NIH Device Record Key76f428e2-defd-4572-83ac-3b90e4a6c074
Commercial Distribution StatusIn Commercial Distribution
Brand NameINE Transducer Arrays White Connector
Version Model NumberINE9000W
Catalog NumberINE9000W
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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 27 Degrees Celsius
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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
Special Storage Condition, SpecifyBetween 0 and 0 *WEEE

Device Identifiers

Device Issuing AgencyDevice ID
GS107290000000003 [Primary]
GS107290107981705 [Package]
Package: Carton Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290000000003]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-20

On-Brand Devices [INE Transducer Arrays White Connector]

07290000000003INE9000W
07290107983365INE9000W

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