microTargeting™ Array Electrode Carrier and Clamp FC1021

GUDID 10873263000615

Array Electrode Carrier and Clamp for microTargeting(TM) Drive

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 10873263000615
• NIH Device Record Key: ac95d685-5818-49eb-b2fe-50f21131c113
• Commercial Distribution Discontinuation: 2025-10-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Array Electrode Carrier and Clamp
• Version Model Number: FC1021-00061-
• Catalog Number: FC1021
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 3
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006948 [Unit of Use]
GS1	10873263000615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011775

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[10873263000615]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-10-02
• Device Publish Date: 2018-07-16

On-Brand Devices [microTargeting™ Array Electrode Carrier and Clamp]

• 00873263000618: Array Electrode Carrier and Clamp for microTargeting(TM) Drive
• 10873263000615: Array Electrode Carrier and Clamp for microTargeting(TM) Drive