microTargeting™ Insertion Tube Set

Basic Information

• Brand Name: microTargeting™ Insertion Tube Set
• Primary DI: 00873263008010
• Version / Model: 66-IT-11P-00801
• Catalog Number: 66-IT-11P
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-25
• Public Version: 1
• Public Version Date: 2019-08-02
• Public Version Status: New
• Public Device Record Key: 8df65930-d152-411c-b9f2-ae6db7b066af

Device Description

microTargeting™ Single Electrode Insertion Tube Set with Bullet Tip Stylet at target, 1x, Sterile. Contains: IT(BP11) Insertion Tube – 219mm tube length, 1.83mm od, 1.6mm id PT(JN11) Protective Tube - 1.27mm od, .84mm id

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: Labeling does not contain MRI Safety Information
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10873263008017	GS1	PK/5	5	In Commercial Distribution
Primary	00873263008010	GS1

Customer Contacts

• Phone: [phone]
• 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