microTargeting™ STar™ Insertion Tube FC9001

GUDID 10873263001216

microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with Nexframe and STar Drive. Each Kit Contains: IT(AR22): Guide Tube - 1.83mm OD, 0.97mm ID (does not enter brain) IT(AR23): Insertion Tube w/ Stylet - 208mm length, 0.90mm OD, 0.60mm ID

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263001216
• NIH Device Record Key: 4fcfe124-3a0d-4cad-a5e2-0dba9f889670
• Commercial Distribution Discontinuation: 2023-01-10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ STar™ Insertion Tube
• Version Model Number: FC9001-00121
• Catalog Number: FC9001
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001219 [Unit of Use]
GS1	10873263001216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092562

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10873263001216]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-20
• Device Publish Date: 2016-08-22

On-Brand Devices [microTargeting™ STar™ Insertion Tube]

• 00873263006528: microTargeting STar Array Electrode Insertion Tube with Stylet, Non-Sterile, for use with microT
• 10873263002305: microTargeting STar Array Electrode Insertion Tube with Stylet, Sterile, for use with microTarge
• 10873263002275: microTargeting STar Array Electrode Insertion Tube with Stylet, Sterile, for use with Stereotact
• 10873263001216: microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with
• 10873263001193: microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use w
• 10873263007652: microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use w
• 10873263007669: microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with