Microtargeting ™ STar Drive Adapter C0305

GUDID 00873263008027

STar Adapter for ROSA Surgical Robot

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263008027
• NIH Device Record Key: e3273cf7-9160-4d79-be1f-06ff613390c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microtargeting ™ STar Drive Adapter
• Version Model Number: C0305-00802
• Catalog Number: C0305
• 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: true
• 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	00873263008027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011775

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263008027]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-02
• Device Publish Date: 2019-07-25

On-Brand Devices [Microtargeting ™ STar Drive Adapter]

• 00873263008027: STar Adapter for ROSA Surgical Robot
• 00873263009291: STar™ Adapter for ROSA® Surgical Robot