microTargeting™ Stylet

Basic Information

• Brand Name: microTargeting™ Stylet
• Primary DI: 00873263008256
• Version / Model: 66-ST-12-00825
• Catalog Number: 66-ST-12
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-05
• Public Version: 2
• Public Version Date: 2021-05-26
• Public Version Status: Update
• Public Device Record Key: 8a24c1c8-1547-4269-a912-3218a8f5a7e3

Device Description

microTargeting DP Stylet, nonsterile, for use with mT Drive and STar 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: Labeling does not contain MRI Safety Information
• 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: ["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
35141	Scalpel, reusable	A hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00873263008256	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011775	000

Device Sizes

Type	Value	Unit	Text
Length	244.5	Millimeter

Storage Conditions

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