DEVICE: Device Bag for the Optune (07290107980029)
Device Identifier (DI) Information
Device Bag for the Optune
BAG 9000_GRAY
Not in Commercial Distribution
90002
NOVOCURE (ISRAEL) LTD
BAG 9000_GRAY
Not in Commercial Distribution
90002
NOVOCURE (ISRAEL) LTD
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep indoors |
Special Storage Condition, Specify: WEEE |
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 |
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No Device Sizes |
Device Record Status
c314b469-dca3-4ce0-9a8c-4ae642c58e9e
April 24, 2019
4
September 20, 2015
April 24, 2019
4
September 20, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-855-281-9301
support@novocure.com
support@novocure.com