microTargeting™ Microtable™ Platform – Single 66-MT-D1

GUDID 00873263006436

microTargeting(TM) Microtable(TM) Platform – Single

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263006436
• NIH Device Record Key: e091963c-5f33-48fc-aa9c-dca7e48b7509
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Microtable™ Platform – Single
• Version Model Number: 66-MT-D1-00643
• Catalog Number: 66-MT-D1
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• 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
• 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
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006436 [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

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

[00873263006436]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-23

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