microTargeting™ Single Electrode Carrier Set 66-EL-EA-01

GUDID 00873263008591

Single Electrode Adapter for IT(ME1), 1x

FHC, INC.

Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive

• Primary Device ID: 00873263008591
• NIH Device Record Key: 1697aeab-1d6b-43be-9cd0-83075bf9ef34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Single Electrode Carrier Set
• Version Model Number: 66-EL-EA-01-00859
• Catalog Number: 66-EL-EA-01
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008591]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263008591]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263008591]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263008591]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263008591]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00873263008591]

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: 2022-06-16
• Device Publish Date: 2022-06-08

On-Brand Devices [microTargeting™ Single Electrode Carrier Set]

• 00873263005132: Single electrode carrier for MicroTargeting(TM) Drive System
• 00873263008591: Single Electrode Adapter for IT(ME1), 1x