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 Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive 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.

• 00873263009208 - microTargeting™ Electrode: 2024-04-22 microTargeting™ Electrode, tungsten, non sterile, 6x, D.ZAP(Z)
• 10873263009212 - microTargeting™ Electrode: 2024-04-12 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 00873263005453 - microTargeting™ Multi-Oblique Accessory: 2024-03-14 Multi-Oblique Sterilization and Storage Kit
• 00873263007044 - microTargeting™ Electrode Sterilization Tray: 2024-03-14 microTargeting Electrode Sterilization Tray
• 00873263002216 - STar™ Drive Frame Adapter Kit: 2024-03-12 STar(TM) Drive Platform Adaptor, Integrated Ring Version
• 00873263002353 - STar™ Drive Frame Adapter: 2024-03-12 STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames
• 00873263002384 - STar™ Drive Positioner: 2024-03-12 Offset Positioner, Short Bushing for STar(TM) Drive
• 00873263002452 - STar™ Drive Positioner: 2024-03-12 Center Positioner, Short Bushing for STar Drive