Visualase Anchor Bolt Tools 9736537

GUDID 00873263009086

Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263009086
• NIH Device Record Key: c27e817c-3354-47e2-899e-30c8748e3be7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visualase Anchor Bolt Tools
• Version Model Number: 9736537-00908
• Catalog Number: 9736537
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263009086 [Primary]

FDA Product Code

• HAO: INSTRUMENT, SURGICAL, NON-POWERED

Sterilization

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

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

[00873263009086]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by FHC, INC.

• 00873263009062 - Visualase Neuro Accessories: 2025-03-18 Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool
• 00873263009079 - Visualase MR Stiffening Stylet: 2025-03-18 Visualase MR Stiffening Stylet (1) MR Stiffening Stylet
• 00873263009086 - Visualase Anchor Bolt Tools: 2025-03-18Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System
• 00873263009086 - Visualase Anchor Bolt Tools: 2025-03-18 Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Aut
• 00873263009093 - Visualase Sterilization & Storage Tray: 2025-03-18 Visualase Sterilization & Storage Tray (1) Sterilization & Storage Tray
• 00873263009109 - Visualase Anchor Bolt Driver: 2025-03-18 Visualase Anchor Bolt Driver (1) Anchor Bolt Driver
• 00873263009116 - Visualase Anchor Bolt Driver Guide: 2025-03-18 Visualase Anchor Bolt Driver Guide for CRW (1) Anchor Bolt Driver Guide for CRW Stereotactic System
• 00873263009123 - Visualase Anchor Bolt Driver Guide: 2025-03-18 Visualase Anchor Bolt Guide for Leksell (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame
• 00873263009130 - Visualase Anchor Bolt Driver Guide: 2025-03-18 Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain