microTargeting™ Electrode and Insertion Tube Kit FC7100

GUDID 10873263007560

Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od

FHC, INC.

Depth electrode

• Primary Device ID: 10873263007560
• NIH Device Record Key: 70923ca6-f20f-4fd0-ae64-5a8371b20145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode and Insertion Tube Kit
• Version Model Number: FC7100-00756
• Catalog Number: FC7100
• 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	00873263007563 [Unit of Use]
GS1	10873263007560 [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

[10873263007560]

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