microTargeting™Array Electrode Insertion Tube Set

Basic Information

Brand Name: microTargeting™Array Electrode Insertion Tube Set
Primary DI: 00873263007600
Version / Model: FC1012-00760
Catalog Number: FC1012
Company Name: FHC, INC.
Labeler DUNS: 108179458
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-12-31
Public Version: 1
Public Version Date: 2020-01-08
Public Version Status: New
Public Device Record Key: 1b5cc5cd-9c73-4a17-a01a-5544e50cef2f

Device Description

microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.

Device Characteristics

Single Use: No
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: Yes
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: No
Sterilization Prior Use: Yes
Sterilization Methods: ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
46863	Neurosurgical micro targeting drive	A calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00873263007600	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011775	000

Storage Conditions

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