microTargeting™ STar™ Electrode Carrier FC8010

GUDID 10873263000851

STar(TM) Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTargeting(TM) Drive

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 10873263000851
• NIH Device Record Key: ba187ccd-954e-40f1-8dc3-eca4582177e5
• Commercial Distribution Discontinuation: 2021-07-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ STar™ Electrode Carrier
• Version Model Number: FC8010-00085
• Catalog Number: FC8010
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 2
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263000854 [Unit of Use]
GS1	10873263000851 [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

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

[10873263000851]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-29
• Device Publish Date: 2016-08-22

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