ITE Transducer Arrays Large White Connector

Basic Information

• Brand Name: ITE Transducer Arrays Large White Connector
• Primary DI: 07290107985383
• Version / Model: ITE1020W
• Catalog Number: ITE1020WUS
• 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: 5
• Public Version Date: 2026-02-16
• Public Version Status: Update
• Public Device Record Key: 7947cc6a-253b-49be-bdcb-bcc8ac451c3e

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
QGZ	Electrical Tumor Treatment Fields	Unknown		3
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer	Unknown		3
SHC	Low Electric Field Generator For Pancreatic Cancer Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58847	Alternating electric field antimitotic cancer treatment system generator	A portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290107985383	GS1
Package	27290107985387	GS1	Carton	5	In Commercial Distribution
Package	37290107985384	GS1	Carton	15	In Commercial Distribution
Package	17290107985380	GS1	Carton	20	In Commercial Distribution

Customer Contacts

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

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