Resident Expert Kinetic Testing Motion Detector C0259

GUDID 00873263008119

Resident Expert Kinetic Testing Motion Detector, 1x

FHC, INC.

Evoked-potential graphic recording system

• Primary Device ID: 00873263008119
• NIH Device Record Key: 0c924d42-3d12-4f05-bdef-465ad7366e11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resident Expert Kinetic Testing Motion Detector
• Version Model Number: C0259-00811
• Catalog Number: C0259
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183123

FDA Product Code

• GZL: ELECTRODE, DEPTH

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-29
• Device Publish Date: 2020-06-20

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