STar™ Drive MA FC8001

GUDID 00873263006368

STar™ Drive MA, manually operated

FHC, INC.

Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive Neurosurgical micro targeting drive

• Primary Device ID: 00873263006368
• NIH Device Record Key: ec42c0f7-488a-44a5-9deb-829fa7167b8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STar™ Drive MA
• Version Model Number: FC8001-00635
• Catalog Number: FC8001
• 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: 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
• 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 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius
• Storage Environment Temperature: Between 0 and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006351 [Primary]
GS1	00873263006368 [Direct Marking]
GS1	00873263008270 [Primary]

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

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

Moist Heat or Steam Sterilization

[00873263006368]

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: 2018-02-05

On-Brand Devices [STar™ Drive MA]

• 00873263006368: STar™ Drive MA, manually operated
• 00873263002124: STar(TM) Drive MA, Manual Operation Only
• 00873263001561: STar(TM) Drive MA, manually operated