Guideline™ 4000 C0217

GUDID 00873263008645

Guideline™ 4000 5.0 Software, Version 2.2.0

FHC, INC.

Neurophysiologic monitoring system

• Primary Device ID: 00873263008645
• NIH Device Record Key: 98bacabe-9f64-4ff5-a18b-e3b438b9f901
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guideline™ 4000
• Version Model Number: C0217-00864
• Catalog Number: C0217
• 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: true
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071364

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: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by FHC, INC.

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• 00873263008706 - NEXDRIVE™ w/DIG: 2025-05-08 MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option
• 00873263008713 - NEXDRIVE™: 2025-05-08 MI-2000 NEXDRIVE™ Micropositioning Drive
• 00873263008720 - Nexprobe®: 2025-05-08 NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation System
• 00873263008904 - microTargeting™ Single Procedure Kit: 2025-05-08 microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tu
• 00873263008928 - microTargeting™ Insertion Tube Set: 2025-05-08 microTargeting Single Electrode Insertion Tube Set Contains: 66-IT-01 (One IT(BP2), One PT(BP2), One Spacer Cleaning Tool, One E
• 00873263008935 - microTargeting™ Insertion Tube Set: 2025-05-08 microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1
• 00873263009031 - microTargeting™ Electrode Cable: 2025-05-08 microTargeting Electrode Cable