Passive Headrest Accessories PH-2510

GUDID 00873263007778

PH-2510 Passive Headrest Accessories

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263007778
• NIH Device Record Key: c86bfae2-37cb-4f91-bc78-4f06a22af3e8
• Commercial Distribution Discontinuation: 2024-03-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Passive Headrest Accessories
• Version Model Number: PH-2510-00777
• Catalog Number: PH-2510
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031885

FDA Product Code

• HBL: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-12
• Device Publish Date: 2020-11-13

Devices Manufactured by FHC, INC.

• 00873263009307 - STar™ Drive Frame Adapter: 2025-02-07 STar™ Frame Adapter, 1x for Leksell Stereotactic System® 1.7 mm
• 00873263009291 - Microtargeting ™ STar Drive Adapter: 2024-11-07 STar™ Adapter for ROSA® Surgical Robot
• 10873263009267 - microTargeting™ Insertion Tube: 2024-10-08 microTargeting™ Insertion Tube with Stylet, 74mm
• 10873263009236 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 10873263009243 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z)
• 00873263009253 - microTargeting™ Electrode: 2024-09-10 microTargeting™ Electrode, tungsten, non-sterile, D.ZAP(Z)
• 00873263009222 - STarFix™ Designer: 2024-07-22 STarFix™ Designer DBS
• 00873263002155 - STar™ Drive M/E: 2024-05-22 STar(TM) Drive ME, Motor/Encoder Version