microTargeting™ STar™ Inerstion Tube Set 70-IT-3007

GUDID 10873263002343

microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(DB7): Insertion Tube - 208mm tube length, 1.83mm od, 1.6mm id. PT(DB7): Protective Tube - 209mm tube length, 1.50mm od, .58mm id.

FHC, INC.

Intracerebral cannula, implantable

• Primary Device ID: 10873263002343
• NIH Device Record Key: d9641ac1-3d6e-4437-a23a-7419e1d2685c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ STar™ Inerstion Tube Set
• Version Model Number: 70-IT-3007-00234
• Catalog Number: 70-IT-3007
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263002346 [Primary]
GS1	10873263002343 [Package]; Contains: 00873263002346; Package: PK/5 [5 Units]; In Commercial Distribution

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

[10873263002343]

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: 2016-09-17

Devices Manufactured by FHC, INC.

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• 00873263002162 - STar™ Drive MA: 2024-05-22 STar(TM) Drive MA, Manual Operation Only
• 00873263002193 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame
• 00873263002223 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
• 00873263002261 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame
• 00873263002643 - STar™ Drive Lead Adapter: 2024-05-22 DBS Lead Adapter for STar(TM) Drive
• 00873263002728 - STar™ Drive Lead Measurement Fixture: 2024-05-22 DBS Lead Measurement Fixture for STar(TM) Drive for use with stereotactic frame