microTargeting™ Electrode Lead Cable C0231

GUDID 00873263006917

GL5 UE Patient Lead, 1.5m, presterile

FHC, INC.

Depth electrode

• Primary Device ID: 00873263006917
• NIH Device Record Key: 05360d3e-032e-45ff-ae38-7f8f16d7f68a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Electrode Lead Cable
• Version Model Number: C0231-00691
• Catalog Number: C0231
• 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: 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

Device Dimensions

• Length: 1.5 Meter

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183123

FDA Product Code

• GZL: ELECTRODE, DEPTH

Sterilization

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

[00873263006917]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-23
• Device Publish Date: 2019-01-02

On-Brand Devices [microTargeting™ Electrode Lead Cable]

• 00873263006917: GL5 UE Patient Lead, 1.5m, presterile
• 00873263006900: GL5 UE Patient Lead, 3m, presterile
• 00873263007815: Guidline 4000 ™ 5.0 1.5m Special-use Lead, 1x For use with microTargeting ™ Electrodes