INE Transducer Arrays Tan Plaster and Black Connector INE9020US

GUDID 07290107985185

FLEXTRONICS ROMANIA SRL

Alternating electric field antimitotic cancer treatment system transducer array
Primary Device ID07290107985185
NIH Device Record Key953d00a9-688d-4a85-964c-10d9d15bcdd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameINE Transducer Arrays Tan Plaster and Black Connector
Version Model NumberINE9TAN
Catalog NumberINE9020US
Company DUNS552446858
Company NameFLEXTRONICS ROMANIA SRL
Device Count20
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
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
GS107290107983839 [Primary]
GS107290107985185 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NZKStimulator, Low Electric Field, Tumor Treatment

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


[07290107985185]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-17
Device Publish Date2021-02-09

Devices Manufactured by FLEXTRONICS ROMANIA SRL

07290107985185 - INE Transducer Arrays Tan Plaster and Black Connector2021-02-17
07290107985185 - INE Transducer Arrays Tan Plaster and Black Connector2021-02-17
07290107985192 - INE Transducer Arrays Tan Plaster and White Connector2021-02-12

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