microTargeting™ Electrode and Insertion Tube Kit FC4001

GUDID 10873263007546

microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007546
• NIH Device Record Key: d068c9b6-7fb6-4bfd-807d-16046f3ba2eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode and Insertion Tube Kit
• Version Model Number: FC4001-00754
• Catalog Number: FC4001
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007549 [Unit of Use]
GS1	10873263007546 [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

[10873263007546]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

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