AccessGUDID - DEVICE: Optune Porteable Battery Rack (07290107981514)

GUDID

Device Identifier (DI) Information

Brand Name: Optune Porteable Battery Rack
Version or Model: PBR9000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 90039
Company Name: Novocure GmbH

Primary DI Number: 07290107981514
Issuing Agency: GS1
Commercial Distribution End Date: April 23, 2019
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
NZK	Stimulator, Low Electric Field, Tumor Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100034	001
P100034	002
P100034	003
P100034	004
P100034	005
P100034	006
P100034	007
P100034	008
P100034	009
P100034	010
P100034	011
P100034	012

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23392366-1e4f-4d53-aa16-eb65e0959448
Public Version Date: April 24, 2019
Public Version Number: 4
DI Record Publish Date: September 20, 2015