NavitrackER 20-8000-000-08

GUDID 00889024304239

Orthosoft Inc

Imaging lesion localization marker, external, single-use

• Primary Device ID: 00889024304239
• NIH Device Record Key: 267a8c67-55ac-49eb-ba92-cc7c3b4719dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NavitrackER
• Version Model Number: 20-8000-000-08
• Catalog Number: 20-8000-000-08
• Company DUNS: 205670032
• Company Name: Orthosoft Inc
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00889024304239 [Primary]
GS1	00889024466340 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030827

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [NavitrackER]

• 00889024305014: 20-8000-070-05
• 00889024304239: 20-8000-000-08
• 00889024304222: 20-8000-000-07