N/A EZ4305NB

GUDID 00850030914064

Tunnel Guide

Microport Navibot International LLC

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• Primary Device ID: 00850030914064
• NIH Device Record Key: 387bdce4-e83c-4aaa-9d55-9a9fb7fd6df0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: E.Z.4305-NB
• Catalog Number: EZ4305NB
• Company DUNS: 118104014
• Company Name: Microport Navibot International LLC
• 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	00850030914064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213873

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

[00850030914064]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2023-01-18

On-Brand Devices [N/A]

• 00850030914064: Tunnel Guide
• 00850030914040: Fixation Component
• 10850030914283: Nail Pouched
• 10850030914276: Long Pin Pouched
• 10850030914269: Standard Pin Pouched
• 10850030914146: Knee Kit Sterilization Tray
• 00850030914118: Osteotomy Probe Probe L Type