DEVICE: microTargeting™ Electrode and Insertion Tube Kit (10873263001346)

Device Identifier (DI) Information

microTargeting™ Electrode and Insertion Tube Kit
KTF1002-00134
In Commercial Distribution
KTF1002
FHC, INC.
10873263001346
GS1
January 10, 2023
5
108179458 *Terms of Use
microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
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Device Characteristics

MR Unsafe
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
Intracerebral cannula, implantable A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.
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
HAO INSTRUMENT, SURGICAL, NON-POWERED
GZL ELECTRODE, DEPTH
HAW Neurological stereotaxic Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1225e8bc-d50a-4dcb-b9ed-c08e99312aa9
December 20, 2019
4
August 22, 2016
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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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 00873263001349 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)326-2905
fhcinc@fh-co.com
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