Navigation SW ENT EM 22241-06A

GUDID 04056481000226

Brainlab AG

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 04056481000226
• NIH Device Record Key: 884e4760-7d3b-4df0-807e-b5f41a3cda5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation SW ENT EM
• Version Model Number: 1.1
• Catalog Number: 22241-06A
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481000226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-13

On-Brand Devices [Navigation SW ENT EM]

• 04056481138813: 1.2
• 04056481000226: 1.1