DEVICE: INE Transducer Array Black Connector (07290000000008)
Device Identifier (DI) Information
INE Transducer Array Black Connector
INE9000
In Commercial Distribution
INE9000
INTEGRA BIOTECHNICAL LLC
INE9000
In Commercial Distribution
INE9000
INTEGRA BIOTECHNICAL LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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 transducer array | A sterile, disposable, head-worn component of an alternating electric field cancer treatment system designed to convert intermediate-frequency (100-300 kHz) alternating electric current to low-intensity alternating electric fields to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Otherwise known as insulated field inducing electrodes (INE), the device is connected to an alternating current generator and consists of an array of ceramic discs contained in a plastic membrane, and is intended to be worn continuously for a period of 3-4 days before disposal. This is single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NZK | Stimulator, Low Electric Field, Tumor Treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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 35 and 50 Percent (%) Relative Humidity |
Storage Environment Temperature: between 5 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ddf1f14f-f0b4-4210-ac0b-353d81a7e149
March 29, 2018
2
September 20, 2015
March 29, 2018
2
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 |
---|---|---|---|---|---|
07290107981781 | 20 | 07290000000008 | In Commercial Distribution | Carton Box |
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