DEVICE: microTargeting™ Electrode and Insertion Tube Kit (00873263005088)
Device Identifier (DI) Information
microTargeting™ Electrode and Insertion Tube Kit
KT-FPK-S20-00508
In Commercial Distribution
KT-FPK-S20
FHC, INC.
KT-FPK-S20-00508
In Commercial Distribution
KT-FPK-S20
FHC, INC.
microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive.
Contains:
34685L: Single D.ZAP Electrode.
66-DA-SD: Drape Sleeve.
66-EL-LP: Patient Lead for LP+.
66-IT-05P: Single Insertion Tube Set.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
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 |
32568 | Neurological stereotactic surgery system |
An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
|
Active | false |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZL | ELECTRODE, DEPTH |
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K011775 | 000 |
K011992 | 000 |
K033173 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 40 Degrees Celsius |
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4b6f5ea5-0801-4ee9-8273-44125bc7de2f
September 23, 2019
4
September 17, 2016
September 23, 2019
4
September 17, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)326-2905
fhcinc@fh-co.com
fhcinc@fh-co.com