AccessGUDID - DEVICE: INE Transducer Array Black Connector (07290000000008)

GUDID

Device Identifier (DI) Information

Brand Name: INE Transducer Array Black Connector
Version or Model: INE9000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INE9000
Company Name: INTEGRA BIOTECHNICAL LLC

Primary DI Number: 07290000000008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079342722 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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.

FDA Product Code

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Product Code	Product Code Name
NZK	Stimulator, Low Electric Field, Tumor Treatment

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

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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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddf1f14f-f0b4-4210-ac0b-353d81a7e149
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2015