Home GUDID 07290000000007 INE Transducer Arrays White Connector
Primary DI 07290000000007
Brand INE Transducer Arrays White Connector
Company INTEGRA BIOTECHNICAL LLC
Model INE9000W
Catalog number INE9000W
Published 2015-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NZK Stimulator, Low Electric Field, Tumor Treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NZK Stimulator, Low Electric Field, Tumor Treatment Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290107981798 Package GS1 20 In Commercial Distribution 07290000000007 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290107981798 07290107981798 7290107981798 07290000000007 07290000000007 7290000000007
GMDN Terms# Term, Definition table Term 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Fragile - handle with care Special Storage Condition, Specify 0 0 Keep away from extreme heat and sources of radiation Special Storage Condition, Specify 0 0 Keep dry Special Storage Condition, Specify 0 0 WEEE Storage Environment Humidity 35 Percent (%) Relative Humidity 50 Percent (%) Relative Humidity Storage Environment Temperature 5 Degrees Celsius 27 Degrees Celsius
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 079342722 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290107985178 INE Transducer Arrays Tan Plaster and White Connector INE9TANW INE9020WUS 2020-12-21 07290107981781 INE Transducer Array Black Connector INE9000 INE9000 2015-09-20
Other Devices Sharing Product Codes# 
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