Unibody™ Bone Fiducials (10mm) FM-4010

GUDID 00873263008560

Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Sterotactic System

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263008560
• NIH Device Record Key: 98785053-5c87-4683-918b-d99af0aa7e35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unibody™ Bone Fiducials (10mm)
• Version Model Number: FM-4010-00856
• Catalog Number: FM-4010
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 6
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008560 [Unit of Use]
GS1	10873263008567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033619

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008560]

Ethylene Oxide

[00873263008560]

Ethylene Oxide

[00873263008560]

Ethylene Oxide

[00873263008560]

Ethylene Oxide

[00873263008560]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-26
• Device Publish Date: 2022-05-18

On-Brand Devices [Unibody™ Bone Fiducials (10mm)]

• 10873263007744: Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Stereotactic System
• 00873263008560: Unibody™ Bone Fiducials (10mm) for use with the Nexframe® Sterotactic System