Patient Tracker

Basic Information

• Brand Name: Patient Tracker
• Primary DI: 07540209955716
• Version / Model: 955-NE-PT
• Company Name: ClaroNav Kolahi Inc
• Labeler DUNS: 203466065
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-27
• Public Version: 2
• Public Version Date: 2026-04-21
• Public Version Status: Update
• Public Device Record Key: ba42b109-4e07-4279-a9cc-5afe6910586e

Device Description

Patient Tracker for Navient

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540209955716	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 70 Degrees Celsius