AccessGUDID - DEVICE: NovoTTF-100L Portable Battery Rack (07290107982979)

GUDID

Device Identifier (DI) Information

Brand Name: NovoTTF-100L Portable Battery Rack
Version or Model: PBR9000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PBR9050US
Company Name: Novocure GmbH

Primary DI Number: 07290107982979
Issuing Agency: GS1
Commercial Distribution End Date: January 08, 2023
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGZ	Electrical Tumor Treatment Fields

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H180002	001

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -5 and 40 Degrees Celsius
Storage Environment Humidity: between 15 and 93 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: 0b8c4694-c61c-435f-919d-6789be81e358
Public Version Date: February 27, 2025
Public Version Number: 3
DI Record Publish Date: December 07, 2020