microTargeting™ STar™ Insertion Tube FC9001

GUDID 10873263007669

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, nonimplantable, single-use

• Primary Device ID: 10873263007669
• NIH Device Record Key: ad6cab9b-c0ef-437c-9749-7ef01fc2463c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ STar™ Insertion Tube
• Version Model Number: FC9001-00766
• 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	00873263007662 [Unit of Use]
GS1	10873263007669 [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

[10873263007669]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

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