Optune HFE transducer array white

Basic Information

• Brand Name: Optune HFE transducer array white
• Primary DI: 07290107985895
• Version / Model: IHEP9020W
• Catalog Number: IHEP9020WUS
• Company Name: Novocure GmbH
• Labeler DUNS: 486647295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-05
• Public Version: 4
• Public Version Date: 2025-06-26
• Public Version Status: Update
• Public Device Record Key: 0d1f2ad5-1995-4ebc-b5bf-ea80a1cf5508

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: 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
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
Primary	07290107985895	GS1
Package	17290107985892	GS1	Carton	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
P100034	033

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 41 – 81 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 41 – 81 Degrees Fahrenheit