INE Transducer Array Black Connector

Basic Information

• Brand Name: INE Transducer Array Black Connector
• Primary DI: 07290107983334
• Version / Model: INE9000
• Catalog Number: INE9000
• Company Name: Novocure GmbH
• Labeler DUNS: 486647295
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 5
• Public Version Date: 2023-01-09
• Public Version Status: Update
• Public Device Record Key: 2f13aae0-6cca-4088-825f-587db2906e2f
• Distribution End Date: 2023-01-08

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZK	Stimulator, Low Electric Field, Tumor Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58846	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07290107981545	GS1	Carton Box	20	Not in Commercial Distribution	2023-01-08
Primary	07290107983334	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: WEEE
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile - handle with care
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from extreme heat and sources of radiation
• Type: Storage Environment Humidity
• Temperature Range: 35 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 27 Degrees Celsius