microTargeting™Array Electrode Insertion Tube Set FC1012

GUDID 00873263007600

microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 00873263007600
• NIH Device Record Key: 1b5cc5cd-9c73-4a17-a01a-5544e50cef2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™Array Electrode Insertion Tube Set
• Version Model Number: FC1012-00760
• Catalog Number: FC1012
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011775

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263007600]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-08
• Device Publish Date: 2019-12-31

On-Brand Devices [microTargeting™Array Electrode Insertion Tube Set]

• 00873263001530: microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains
• 00873263007600: microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains