microTargeting™ STar™ Insertion Tube Set FC9003

GUDID 10873263007683

microTargeting STar Drive Single Electrode Insertion Tube Set, 5x, Sterile, for use with Nexframe and STar Drive. Contains: IT(DB7): Insertion Tube with Stylet - 205.6mm length, 1.83mm OD, 1.6mm ID PT(DB7) Protective Tube - 1.50mm OD, 0.58mm ID

FHC, INC.

Intracerebral cannula, nonimplantable, single-use

• Primary Device ID: 10873263007683
• NIH Device Record Key: ecfadf5c-393e-47a9-9fa1-04ea23409192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ STar™ Insertion Tube Set
• Version Model Number: FC9003-00768
• Catalog Number: FC9003
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 5
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007686 [Unit of Use]
GS1	10873263007683 [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: true

[10873263007683]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

On-Brand Devices [microTargeting™ STar™ Insertion Tube Set]

• 10873263002336: microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar
• 10873263001230: microTargeting STar Drive Single Electrode Insertion Tube Set, 5x, Sterile, for use with Nexfram
• 10873263007683: microTargeting STar Drive Single Electrode Insertion Tube Set, 5x, Sterile, for use with Nexfram