STar™ Drive Frame Adapter

Basic Information

• Brand Name: STar™ Drive Frame Adapter
• Primary DI: 00873263002292
• Version / Model: 70-FA-LX-01-00229
• Catalog Number: 70-FA-LX-01
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 4
• Public Version Date: 2021-06-15
• Public Version Status: Update
• Public Device Record Key: 9d64c4ea-dfe7-4995-9231-35b83e7e8b7e

Device Description

STar(TM) Drive Offseting Frame Adapter for use with Leksell Stereotactic Frame

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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: 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
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
Direct Marking	00873263002032	GS1
Primary	00873263002292	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092562	000

Storage Conditions

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