microTargeting™ Drive System MT-DS

GUDID 00873263003527

microTargeting Drive System Contains: -microTargeting Manual Drive -Drive Mount and Guide -microTargeting(TM) Sterilization Case -Verfication Probe -DBS Measurement Fixture -DBS Adapter for microTargeting(TM) Drive - Accessories kit -Matrix Guide Bushings -Lumen Cleaning Tool

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263003527
• NIH Device Record Key: 6a351965-9d68-42e1-86da-3862ce12a8fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Drive System
• Version Model Number: MT-DS-00352
• Catalog Number: MT-DS
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003527 [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

[00873263003527]

Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ Drive System]

• 00873263003527: microTargeting Drive System Contains: -microTargeting Manual Drive -Drive Mount and Guide -micro
• 00873263003503: microTargeting(TM) Drive System compatible with mT Controller Contains: - Verification Probe - m
• 00873263001479: microTargeting Drive System