INE Transducer Arrays White Connector INE9000W

GUDID 07290000000007

INTEGRA BIOTECHNICAL LLC

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290000000007
NIH Device Record Keyd13a4e34-67b7-4a4a-a40e-8316c1180a6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameINE Transducer Arrays White Connector
Version Model NumberINE9000W
Catalog NumberINE9000W
Company DUNS079342722
Company NameINTEGRA BIOTECHNICAL LLC
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

Special Storage Condition, SpecifyBetween 0 and 0 *WEEE
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile - handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from extreme heat and sources of radiation
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290000000007 [Primary]
GS107290107981798 [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

[07290000000007]

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]

07290000000007INE9000W
07290107983396INE9000W

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