NAV1

Basic Information

• Brand Name: NAV1
• Primary DI: 04048551291030
• Version / Model: 40810020
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-23
• Public Version: 1
• Public Version Date: 2018-09-24
• Public Version Status: New
• Public Device Record Key: b5f0035b-8e87-4f4e-ada0-aacc8c0a5cb7

Device Description

NAV1-Module

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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
61408	Optical surgical navigation device tracking system workstation, stationary	A mains electricity (AC-powered) component of an optical surgical navigation device tracking system intended to serve as a user interface for controlling the function of the system during computer assisted surgery (CAS). It consists of a stationary computer unit with an image display screen, a mobile infrared (IR) light camera, and integrated software. The system provides an optical tool for the tracking of instruments and patient with respect to pre-acquired images (e.g., CT or MRI scan), or real-time image data [e.g., ultrasound (US) data].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551291030	GS1

Premarket Submissions

Submission Number	Supplement Number
K122096	000