DEVICE: microTargeting™ Electrode and Insertion Tube Kit (10873263001346)
Device Identifier (DI) Information
microTargeting™ Electrode and Insertion Tube Kit
KTF1002-00134
Not in Commercial Distribution
KTF1002
FHC, INC.
KTF1002-00134
Not in Commercial Distribution
KTF1002
FHC, INC.
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
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61964 | 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.
|
Active | true |
32556 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAO | INSTRUMENT, SURGICAL, NON-POWERED |
GZL | ELECTRODE, DEPTH |
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1225e8bc-d50a-4dcb-b9ed-c08e99312aa9
January 10, 2023
5
August 22, 2016
January 10, 2023
5
August 22, 2016
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:
00873263001349
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)326-2905
fhcinc@fh-co.com
fhcinc@fh-co.com