microTargeting™ Electrodes

Basic Information

• Brand Name: microTargeting™ Electrodes
• Primary DI: 10873263001179
• Version / Model: FC5000-00117
• Catalog Number: FC5000
• 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: 54387674-a6c6-4b27-9c97-eb5732922e05
• Distribution End Date: 2023-01-10

Device Description

microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.

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

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10873263001179	GS1
Unit of Use	00873263001172	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033173	000

Device Sizes

Type	Value	Unit	Text
Length	249.2	Millimeter
Length	10	Millimeter
Length	234.2	Millimeter
Device Size Text, specify			Impedance: Megaohms
Length	0.56	Millimeter

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