microTargeting™ Controller with Encoder FC1007

GUDID 00873263001431

microTargeting Controller with encoder option for use with STar and mT Drives

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263001431
• NIH Device Record Key: fa3bcd55-a694-4a88-a6d1-a073121799e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Controller with Encoder
• Version Model Number: FC1007-00143
• Catalog Number: FC1007
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

Devices Manufactured by FHC, INC.

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• 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