Radian

GUDID 00810135961431

Instrument: Drill and Screw Guide Holding Screw. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00810135961431
• NIH Device Record Key: 8dd81bff-98bb-442a-b9d4-01933a377097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radian
• Version Model Number: BUN-1000T-SGHS
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, 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: true
• Serial Number: false
• 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: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810135961431 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

[00810135961431]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-12
• Device Publish Date: 2024-06-04

Devices Manufactured by NVISION BIOMEDICAL TECHNOLOGIES, INC.

• 00810135962377 - Trigon: 2025-08-04 6mmx30mm radius PEEK small standard midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for int
• 00810135962384 - Trigon: 2025-08-04 6mmx30mm radius PEEK large standard midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for int
• 00810135962391 - Trigon: 2025-08-04 6mmx70mm radius PEEK small wide midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for interna
• 00810135962407 - Trigon: 2025-08-04 6mmx70mm radius PEEK large wide midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for interna
• 00810135962834 - Vertex: 2025-08-04 Instrument: 3.0mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and th
• 00810135962865 - Trigon: 2025-08-04 Midfoot Wedge Standard Screw Targeting Guide Assembly The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for
• 00810135962889 - Trigon: 2025-08-04 Midfoot Wedge Kwire Sleeve The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for
• 00810135962896 - Trigon: 2025-08-04 Midfoot Wedge Staple Drill Guide The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixati