microTargeting™ Array Electrode Insertion Tube Set 66-IT-1018

GUDID 10873263004033

microTargeting Array Electrode Insertion Tube Set, Sterile, for use with Stereotactic Frame and mT Drive System. Contains: IT(AR1): Insertion Tube with Stylet - 239.9mm tube length, 1.07mm OD, .89mm ID IT(AR2): Lower Guide Insertion Tube - 1.83mm OD, .97mm ID

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263004033
• NIH Device Record Key: 00108745-5ea2-43dc-8a66-2faf9a307e88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Array Electrode Insertion Tube Set
• Version Model Number: 66-IT-1018-00403
• Catalog Number: 66-IT-1018
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263004036 [Primary]
GS1	10873263004033 [Package]; Contains: 00873263004036; Package: PK/5 [5 Units]; In Commercial Distribution

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: true

[10873263004033]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

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

• 10873263004033: microTargeting Array Electrode Insertion Tube Set, Sterile, for use with Stereotactic Frame and
• 00873263001318: microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains