MacroStim Interface (MSI) 66-EL-MI

GUDID 00873263004227

MacroStim Interface

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263004227
• NIH Device Record Key: e1d6fa3e-8d41-4fce-8ee4-fdfe8eeb036f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MacroStim Interface (MSI)
• Version Model Number: 66-EL-MI-00422
• Catalog Number: 66-EL-MI
• 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: 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 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263004227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

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

Devices Manufactured by FHC, INC.

• 00873263009222 - STarFix™ Designer: 2024-07-22 STarFix™ Designer DBS
• 00873263002155 - STar™ Drive M/E: 2024-05-22 STar(TM) Drive ME, Motor/Encoder Version
• 00873263002162 - STar™ Drive MA: 2024-05-22 STar(TM) Drive MA, Manual Operation Only
• 00873263002193 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger ZD stereotactic frame
• 00873263002223 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Leibinger RM stereotactic frame
• 00873263002261 - STar™ Drive Frame Adapter: 2024-05-22 STar(TM) Drive Frame Adapter for use with Radionics CRW stereotactic frame
• 00873263002643 - STar™ Drive Lead Adapter: 2024-05-22 DBS Lead Adapter for STar(TM) Drive
• 00873263002728 - STar™ Drive Lead Measurement Fixture: 2024-05-22 DBS Lead Measurement Fixture for STar(TM) Drive for use with stereotactic frame