DEVICE: Optune Porteable Battery Rack (07290107980289)

Device Identifier (DI) Information

Optune Porteable Battery Rack
PBR9000
In Commercial Distribution
90039
NOVOCURE (ISRAEL) LTD
07290107980289
GS1

1
532457256 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
NZK Stimulator, Low Electric Field, Tumor Treatment
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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
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3c79cb01-2ee8-4e53-bde0-711dafae03d7
July 06, 2018
3
September 20, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1-855-281-9301
support@novocure.com
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