DEVICE: INE Transducer Array Black Connector (07290000000008)

Device Identifier (DI) Information

INE Transducer Array Black Connector
INE9000
In Commercial Distribution
INE9000
INTEGRA BIOTECHNICAL LLC
07290000000008
GS1

1
079342722 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Alternating electric field antimitotic cancer treatment system transducer array A sterile, disposable, head-worn component of an alternating electric field cancer treatment system designed to convert intermediate-frequency (100-300 kHz) alternating electric current to low-intensity alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Otherwise known as insulated field inducing electrodes (INE), the device is connected to an alternating current generator and consists of an array of ceramic discs contained in a plastic membrane, and is intended to be worn continuously for a period of 3-4 days before disposal. This is single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
NZK Stimulator, Low Electric Field, Tumor Treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P100034 001
P100034 002
P100034 003
P100034 004
P100034 005
P100034 006
P100034 007
P100034 008
P100034 009
P100034 010
P100034 011
P100034 012
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Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: WEEE
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile - handle with care
Special Storage Condition, Specify: Keep away from extreme heat and sources of radiation
Storage Environment Humidity: between 35 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 27 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ddf1f14f-f0b4-4210-ac0b-353d81a7e149
July 06, 2018
3
September 20, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07290107981781 20 07290000000008 In Commercial Distribution Carton Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-855-281-9301
support@novocure.com
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