Navident

GUDID 07540209955006

Navident Surgical Navigation System - Packaged System (including kits/accessories)

Claronav Inc

Surgical planning/navigation-enhancement system

• Primary Device ID: 07540209955006
• NIH Device Record Key: 00416d90-7e3d-400e-af1e-28f6bbd8e35a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navident
• Version Model Number: 955-ND-ND, plus kits
• Company DUNS: 207008769
• Company Name: Claronav Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	07540209955006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161406

FDA Product Code

• PLV: Dental Stereotaxic Instrument
• QRY: Dental Navigation System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-15
• Device Publish Date: 2024-05-07

On-Brand Devices [Navident]

• 07540209990014: Navident Surgical Navigation System
• 07540209955938: Calibrator
• 07540209955921: NaviTray
• 07540209955914: Jaw Tracker T (JTT43)
• 07540209955907: JawTracker T (JTT42)
• 07540209955891: Jaw Tracker T (JTT41)
• 07540209955884: Jaw Tracker 4U
• 07540209955877: Jaw Tracker 4C
• 07540209955860: Jaw Tracker 4B
• 07540209955853: High Speed Handpiece Tracker (HPT HS)
• 07540209955846: Low Speed Handpiece Tracker (HPT LS)
• 07540209955839: Tracer 4
• 07540209955822: Jaw Tracker T (JTT33)
• 07540209955815: Jaw Tracker T (JTT32)
• 07540209955808: Jaw Tracker T (JTT31)
• 07540209955792: Jaw Tracker U
• 07540209955785: Jaw Tracker C
• 07540209955778: Jaw Tracker B
• 07540209955761: Tracer 3
• 07540209955952: Handpiece Tracker (HPT)
• 07540209955006: Navident Surgical Navigation System - Packaged System (including kits/accessories)