microTargeting™ Electrode and Insertion Tube Kit KT-FPK-S20

GUDID 00873263005088

microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive. Contains: 34685L: Single D.ZAP Electrode. 66-DA-SD: Drape Sleeve. 66-EL-LP: Patient Lead for LP+. 66-IT-05P: Single Insertion Tube Set.

FHC, INC.

Depth electrode

• Primary Device ID: 00873263005088
• NIH Device Record Key: 4b6f5ea5-0801-4ee9-8273-44125bc7de2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode and Insertion Tube Kit
• Version Model Number: KT-FPK-S20-00508
• Catalog Number: KT-FPK-S20
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

• 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	00873263005088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011775

FDA Product Code

• GZL: ELECTRODE, DEPTH

Sterilization

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

[00873263005088]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ Electrode and Insertion Tube Kit]

• 00873263005088: microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive.
• 10873263001346: microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame
• 10873263001322: Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTarg
• 10873263001162: microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDri
• 10873263007584: microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame
• 10873263007560: Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTarg
• 10873263007546: microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDri