NAV1

GUDID 04048551336854

NAV1 ELECTROMAGNETIC Module

Karl Storz GmbH & Co. KG

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 04048551336854
• NIH Device Record Key: 66687e9e-7816-40ad-a6e2-c669cea789df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAV1
• Version Model Number: 40820020
• Company DUNS: 315731430
• Company Name: Karl Storz GmbH & Co. KG
• 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: 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	04048551336854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161555

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2018-08-23

On-Brand Devices [NAV1]

• 04048551337820: NAV1 ELECTROMAGNETIC Field Generator
• 04048551336854: NAV1 ELECTROMAGNETIC Module
• 04048551291030: NAV1-Module
• 04048551009901: NAV1 pico Mobile Stand