DEVICE: NeuroNav Drive Headstage Kit (27290016450174)

Device Identifier (DI) Information

NeuroNav Drive Headstage Kit
NeuroNav Drive Headstage Kit
In Commercial Distribution
700-026000-00
ALPHA OMEGA ENGINEERING CO. LTD.
27290016450174
GS1

1
531856466 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
No
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
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

[?]
Product Code Product Code Name
GZL Electrode, Depth
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K172042 000
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Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c802b5d3-0c7c-4876-b0b1-8dbb8edcc4e3
November 22, 2019
3
August 20, 2019
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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
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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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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