microTargeting™ Lead Insertion Tube with Stylet 66-IT-AR14P

GUDID 10873263006495

microTargeting™ Lead Insertion Tube with Stylet, Sterile, for use with stereotactic frame, 5x

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 10873263006495
• NIH Device Record Key: c4136f5a-5b19-4134-83ac-b8458e6cd9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Lead Insertion Tube with Stylet
• Version Model Number: 66-IT-AR14P-00649
• Catalog Number: 66-IT-AR14P
• 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

Device Dimensions

• Length: 267.85 Millimeter
• Length: 267.85 Millimeter
• Length: 267.85 Millimeter

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	00873263006498 [Primary]
GS1	10873263006495 [Package]; Contains: 00873263006498; 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

[10873263006495]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-05

Devices Manufactured by FHC, INC.

• 00873263009291 - Microtargeting ™ STar Drive Adapter: 2024-11-07 STar™ Adapter for ROSA® Surgical Robot
• 10873263009267 - microTargeting™ Insertion Tube: 2024-10-08 microTargeting™ Insertion Tube with Stylet, 74mm
• 10873263009236 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 10873263009243 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 00873263009253 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
• 00873263009222 - STarFix™ Designer: 2024-07-22 STarFix™ Designer DBS
• 00873263002155 - STar™ Drive M/E: 2024-05-22 STar(TM) Drive ME, Motor/Encoder Version
• 00873263002162 - STar™ Drive MA: 2024-05-22 STar(TM) Drive MA, Manual Operation Only