microTargeting™ Electrode and Insertion Tube Kit

Basic Information

• Brand Name: microTargeting™ Electrode and Insertion Tube Kit
• Primary DI: 10873263001322
• Version / Model: FC7100-00132
• Catalog Number: FC7100
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 6
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: a172ff84-6530-4663-9b94-c35d3a52319f
• Distribution End Date: 2023-01-10

Device Description

Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od

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", "Moist Heat or Steam Sterilization"]

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
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.	Yes	Active
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10873263001322	GS1
Unit of Use	00873263001325	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K011775	000
K033173	000

Storage Conditions

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