DEVICE: Auragen™ (10381780036524)

Device Identifier (DI) Information

Auragen™
AU8D10L5
In Commercial Distribution

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
10381780036524
GS1

1
531408342 *Terms of Use
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
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
Depth electrode An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GYC ELECTRODE, CORTICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K926424 000
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Sterilization

Yes
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: Room temperature
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 8 platinum contacts
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Device Record Status

ec364f88-59d7-4fe9-b0b9-14f8c2349fa2
September 23, 2019
4
August 08, 2016
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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
HIBCC M272AU8D10L51
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+1(800)654-2873
custsvcnj@integralife.com
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