ITE Transducer Arrays Small Black Connector

Basic Information

• Brand Name: ITE Transducer Arrays Small Black Connector
• Primary DI: 07290107984072
• Version / Model: ITE1013B
• Catalog Number: ITE1013BUS
• Company Name: Novocure GmbH
• Labeler DUNS: 486647295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-09
• Public Version: 4
• Public Version Date: 2025-04-18
• Public Version Status: Update
• Public Device Record Key: 6bf73c4b-af3a-47fc-8bcc-062ebc3f0fd4

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer	Unknown		3
QGZ	Electrical Tumor Treatment Fields	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
Primary	07290107984072	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H180002	001
H180002	003
P230042	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 27 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 35 – 50 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from extreme heat and sources of radiation
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile - handle with care
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: WEEE