NAVITRACK

GUDID 00889024304390

Orthosoft Inc

Surgical drill guide, reusable

• Primary Device ID: 00889024304390
• NIH Device Record Key: 5873c130-64ef-459c-be8e-e93c24a4a051
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAVITRACK
• Version Model Number: 20-8000-010-16
• Company DUNS: 205670032
• Company Name: Orthosoft 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: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024304390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110054

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00889024304390]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-05-05

On-Brand Devices [NAVITRACK]

• 00889024304390: 20-8000-010-16
• 00889024489158: 20-8000-020-22