NaviENT

GUDID 07540209955099

NaviENT surgical navigation system

ClaroNav Kolahi Inc

Surgical planning/navigation-enhancement system

• Primary Device ID: 07540209955099
• NIH Device Record Key: ef5a8016-84bf-4e41-b300-718943fd21d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviENT
• Version Model Number: 955-NE-NE
• Company DUNS: 203466065
• Company Name: ClaroNav Kolahi 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	07540209955099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163439

FDA Product Code

• PGW: Ear, Nose, And Throat 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 Kolahi Inc

• 07540209955501 - Navient System with kits: 2025-03-10 Navient System 955-NC-NC with kits
• 07540209955518 - Navient Accessory kit - cranial: 2025-03-10 Navient Accessory kit for use with Navient system, cranial
• 07540209955525 - Navient Accessory kit - biopsy: 2025-03-10 Navient Accessory kit - biopsy for use with Navient system, cranial
• 07540209955723 - Universal Tracker Biopsy: 2025-03-10 Universal Tracker Biopsy for use with Navient system, cranial
• 07540209955730 - Universal Tracker Cusa: 2025-03-10 Universal Tracker Cusa for use with Navient system, cranial
• 07540209955747 - Universal Tracker Stimulation probe: 2025-03-10 Universal Tracker Stimulation probe for use with Navient system, cranial
• 07540209955754 - Universal Tracker Suction: 2025-03-10 Universal Tracker Suction for use with Navient system, cranial
• 07540209955945 - Navigated Shunt Needle: 2025-03-10 Navigated Shunt Needle for use with Navient system, cranial