microTargeting™ Platform Tool Guide 66-WP-TG18MM

GUDID 00873263003626

microTargeting Platform Tool Guide, 1x, nonsterile

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263003626
• NIH Device Record Key: 7f88c86e-7873-4a08-9648-3e38c1403058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Platform Tool Guide
• Version Model Number: 66-WP-TG18MM-00362
• Catalog Number: 66-WP-TG18MM
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Device Dimensions

• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter
• Lumen/Inner Diameter: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263003626]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-27
• Device Publish Date: 2016-09-17

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