Navident Procedure Kit

GUDID 07540209990021

Navident Procedure Kit - for use with the Navident System (955-ND-ND).

Claronav Inc

Surgical planning/navigation-enhancement system

• Primary Device ID: 07540209990021
• NIH Device Record Key: 4b03d94e-6bbb-4ea4-bfa8-4c5788a4d60f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navident Procedure Kit
• Version Model Number: 955-ND-PRK
• Company DUNS: 207008769
• Company Name: Claronav 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: true
• Device Combination Product: false
• Single Use: true
• 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	07540209990021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161406

FDA Product Code

• PLV: Dental Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-03

Devices Manufactured by Claronav Inc

• 07540209955006 - Navident: 2024-05-15 Navident Surgical Navigation System - Packaged System (including kits/accessories)
• 07540209956232 - MicronMapper: 2024-05-15 Software for MicronMapper and MicronMapper EVO Dental Metrology Systems
• 07540209956249 - MicronMapper EVO: 2024-05-15 Set of 10 MicronMapper EVO Scan Bodies with autoclavable container
• 07540209956256 - MicronMapper: 2024-05-15 MicronMapper (Full System), including: MicronMapper Camera, MicronMapper Software, and Scan Bodies
• 07540209956263 - MicronMapper EVO: 2024-05-15 MicronMapper EVO (Full System), including: MicronMapper Software and MicronMapper EVO Scan Bodies. To be used in combination wit
• 07540209955952 - Navident: 2024-03-04 Handpiece Tracker (HPT)
• 07540209956218 - MicronMapper: 2023-11-14 MicronMapper Optical Dental Metrology System
• 07540209956225 - MicronMapper: 2023-11-14 Set of 10 Scan Bodies with autoclavable container