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.

• 00810135963268 - Impact: 2025-10-02 PEEK Union Nail 3.0 countersink shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation o
• 00810135963282 - Impact: 2025-10-02 PEEK Union Nail 4.0 Countersink Shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation o
• 00810135963329 - Impact: 2025-10-02 PEEK Nail Cutter 4.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fracture
• 00810135963374 - Impact: 2025-10-02 PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fracture
• 00810135963404 - Impact: 2025-10-02 Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, os
• 00810135963411 - Impact: 2025-10-02 PEEK Nail Slap Hammer The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures
• 00810135963640 - Impact: 2025-10-02 Kwire 1.4mmx127mm single trocar The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone
• 00810135963657 - Impact: 2025-10-02 Mallet The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies,