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

• 07540209956812 - TissueMapper: 2025-06-23 TissueMapper (Variant A). Optional accessory to MicronMapper used for capturing soft tissue morphology/ridge height.
• 07540209956829 - TissueMapper: 2025-06-23 TissueMapper (Variant B). Optional accessory to MicronMapper used for capturing soft tissue morphology/ridge height.
• 07540209956546 - MicronMapper: 2025-03-11 MicronMapper Scan Bodies (Model 950-MM1-SCAN-BDY), Set of 10: 10-19
• 07540209956553 - MicronMapper: 2025-03-11 MicronMapper Scan Bodies (Model 950-MM1-SCAN-BDY), Set of 10: 20-29
• 07540209956560 - MicronMapper: 2025-03-11 MicronMapper Scan Bodies (Model 950-MM1-SCAN-BDY), Set of 10: 30-39
• 07540209956577 - MicronMapper: 2025-03-11 MicronMapper Scan Bodies (Model 950-MM1-SCAN-BDY), Set of 10: 40-49
• 07540209956584 - MicronMapper: 2025-03-11 MicronMapper Split Scan Bodies (Model 950-MM1-SPLT-BDY), Set 10-17
• 07540209956591 - MicronMapper: 2025-03-11 MicronMapper Split Scan Bodies (Model 950-MM1-SPLT-BDY), Set 20-27