microTargeting™ Microtable™ Platform – Sequential 66-MT-D2

GUDID 10873263006440

microTargeting(TM) Microtable(TM) Platform – Sequential

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 10873263006440
• NIH Device Record Key: 65b1a16e-efcb-450d-bc57-327ae51fe79d
• Commercial Distribution Discontinuation: 2022-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Microtable™ Platform – Sequential
• Version Model Number: 66-MT-D2-00644
• Catalog Number: 66-MT-D2
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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
• 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
• 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
• 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	00873263006443 [Unit of Use]
GS1	10873263006440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132611

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

[10873263006440]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-10-04
• Device Publish Date: 2018-01-23

Devices Manufactured by FHC, INC.

• 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
• 00873263002995 - STar™ Drive SteriSuite Case: 2024-05-22 Sterilzation Wire Basket for STar(TM) Drive System