NAV1

GUDID 04048551337820

NAV1 ELECTROMAGNETIC Field Generator

Karl Storz GmbH & Co. KG

Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system

• Primary Device ID: 04048551337820
• NIH Device Record Key: 2d7820cd-a1a8-4ce2-a2ee-cf9f5422f49b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAV1
• Version Model Number: 40820030
• 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	04048551337820 [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