DEVICE: Optune Gio (07290107986427)
Device Identifier (DI) Information
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. 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 | 012 |
| P100034 | 013 |
| P100034 | 014 |
| P100034 | 015 |
| P100034 | 016 |
| P100034 | 017 |
| P100034 | 018 |
| P100034 | 019 |
| P100034 | 020 |
| P100034 | 021 |
| P100034 | 022 |
| P100034 | 023 |
| P100034 | 031 |
| P100034 | 032 |
| P100034 | 033 |
| P100034 | 034 |
| P100034 | 035 |
| P100034 | 036 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| 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 |
|---|
| No Device Sizes |
Device Record Status
85fd2dc2-40e1-48e1-a479-75765bf60ae3
March 14, 2025
1
March 06, 2025
March 14, 2025
1
March 06, 2025
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