microTargeting™ Guideline 4000™ 5.0 Remote Control C0222

GUDID 00873263006849

microTargeting(TM) Guideline 4000(TM) 5.0 Remote Control

FHC, INC.

Neurophysiologic monitoring system

• Primary Device ID: 00873263006849
• NIH Device Record Key: e8336f46-7e60-4f32-9088-0d1605968c28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Guideline 4000™ 5.0 Remote Control
• Version Model Number: C0222-00684
• Catalog Number: C0222
• 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 Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006849 [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: 2019-02-04
• Device Publish Date: 2019-01-02

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• 00873263007044 - microTargeting™ Electrode Sterilization Tray: 2024-03-14 microTargeting Electrode Sterilization Tray
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• 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