microTargeting™ Single Procedure Kit

Basic Information

Brand Name: microTargeting™ Single Procedure Kit
Primary DI: 00873263007570
Version / Model: KTF1001-00757
Catalog Number: KTF1001
Company Name: FHC, INC.
Labeler DUNS: 108179458
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-12-27
Public Version: 3
Public Version Date: 2021-12-22
Public Version Status: Update
Public Device Record Key: 63ecf005-f962-4b67-a46d-31c319b1bbb7

Device Description

microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Unsafe
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: Yes
Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZL	ELECTRODE, DEPTH	Neurology	882.1330	2
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
47783	Patient surgical drape, single-use	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.	No	Active
62753	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00873263007570	GS1

Customer Contacts

Phone: +1(800)326-2905
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K011775	000
K033173	000
K071364	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 0 – 40 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 0 – 95 Percent (%) Relative Humidity
Type: Handling Environment Humidity
Temperature Range: 0 – 95 Percent (%) Relative Humidity