AccessGUDID - DEVICE: microTargeting™ Electrode and Insertion Tube Kit (10873263007546)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Electrode and Insertion Tube Kit
Version or Model: FC4001-00754
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FC4001
Company Name: FHC, INC.

Primary DI Number: 10873263007546
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.
Intracerebral cannula, nonimplantable, single-use	A sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.

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.

Intracerebral cannula, nonimplantable, single-use

A sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
GZL	ELECTRODE, DEPTH
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011775	000
K033173	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d068c9b6-7fb6-4bfd-807d-16046f3ba2eb
Public Version Date: January 06, 2020
Public Version Number: 1
DI Record Publish Date: December 27, 2019