Star™ Drive M/E FC8002

GUDID 00873263001578

STar(TM) Drive M/E, Motor/Encoder version

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263001578
• NIH Device Record Key: 2592ce85-eb8e-4519-8623-a9da6eb4bfa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Star™ Drive M/E
• Version Model Number: FC8002-00149
• Catalog Number: FC8002
• 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
• 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
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001493 [Primary]
GS1	00873263001578 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092562

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

Moist Heat or Steam Sterilization

[00873263001578]

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: 2016-08-22

On-Brand Devices [Star™ Drive M/E]

• 00873263006382: STar™ Drive M/E, Motor/Encoder version
• 00873263002131: STar(TM) Drive ME, Motor/Encoder Version
• 00873263001578: STar(TM) Drive M/E, Motor/Encoder version
• 00873263008287: STar™ Drive M/E, Motor/Encoder version
• 00873263002155: STar(TM) Drive ME, Motor/Encoder Version