Virage Navigation System

GUDID 03662663063494

Drill Guide Reference Array

ZIMMER BIOMET INC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit 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

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