AccessGUDID - DEVICE: ITE Transducer Arrays Small White Connector (07290107985352)

GUDID

Device Identifier (DI) Information

Brand Name: ITE Transducer Arrays Small White Connector
Version or Model: ITE1013B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITE1013BUS
Company Name: Novocure GmbH

Primary DI Number: 07290107985352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486647295 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
QGZ	Electrical Tumor Treatment Fields

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H180002	001
H180002	003
P230042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8fec9694-6625-4534-bb42-350cbd8a7906
Public Version Date: February 27, 2025
Public Version Number: 4
DI Record Publish Date: October 09, 2024