Navident Accessory Kit

GUDID 07540209955037

Navident accessory kit for use with Navident System

Claronav Inc

Surgical planning/navigation-enhancement system

• Primary Device ID: 07540209955037
• NIH Device Record Key: c44f5a6c-e72e-4e71-9c0d-1a8edfc03915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navident Accessory Kit
• Version Model Number: 955-ND-ACCK
• 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: false
• Lot Batch: false
• 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	07540209955037 [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

• 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
• 07540209956607 - MicronMapper: 2025-03-11 MicronMapper Split Scan Bodies (Model 950-MM1-SPLT-BDY), Set 30-37
• 07540209956614 - MicronMapper: 2025-03-11 MicronMapper Split Scan Bodies (Model 950-MM1-SPLT-BDY), Set 40-47