Virage Navigation System

GUDID 03662663063494

Drill Guide Reference Array

ZIMMER BIOMET INC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03662663063494
• NIH Device Record Key: 276b62a9-f1a6-43aa-8e63-d94920eaf079
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Virage Navigation System
• Version Model Number: 131T3001
• Company DUNS: 045576443
• Company Name: ZIMMER BIOMET 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663063494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240647

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

[03662663063494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [Virage Navigation System]

• 00887868517099: VIRAGE NAV 5.0MM LARGE TAP
• 00887868517082: VIRAGE NAV 4.5MM LARGE TAP
• 00887868517075: VIRAGE NAV 4.0MM LARGE TAP
• 00887868517068: VIRAGE NAV 3.5MM SMALL TAP
• 00887868517051: VIRAGE NAV 3.0MM SMALL TAP
• 00887868517044: VIRAGE NAV D2.3MM DRILL BIT
• 00887868516986: Virage Navigation Poly Screw Driver
• 03662663063494: Drill Guide Reference Array