microTargeting™ Electrode

Basic Information

• Brand Name: microTargeting™ Electrode
• Primary DI: 10873263008796
• Version / Model: 34680-00879
• Catalog Number: 34680
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 1
• Public Version Date: 2025-05-08
• Public Version Status: New
• Public Device Record Key: a578b979-e3f9-41b3-a351-32f7dfbae14c

Device Description

microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive

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: Yes
• 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

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
Unit of Use	00873263008799	GS1
Primary	10873263008796	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033173	000

Device Sizes

Type	Value	Unit	Text
Length	10	Millimeter
Length	256.4	Millimeter
Length	271.4	Millimeter
Device Size Text, specify			Impedance: Megaohms
Outer Diameter	0.77	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 95 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Degrees Celsius