microTargeting™ STar™ Insertion Tube 70-IT(AR5)

GUDID 00873263006528

microTargeting STar Array Electrode Insertion Tube with Stylet, Non-Sterile, for use with microTargeting Platform. Contains: IT(AR18): Insertion Tube - 1.83mm od, .97mm id (does not enter brain) IT(AR19): Insertion Tube - 186.7mm tube length, .90mm od, .60mm id

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 00873263006528
• NIH Device Record Key: 2f2c7e36-47ec-47d0-a1b2-5af9d447eede
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ STar™ Insertion Tube
• Version Model Number: 70-IT(AR5)-00652
• Catalog Number: 70-IT(AR5)
• 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: 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
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006528 [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: false

[00873263006528]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-04

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