Navigation Software Spine & Trauma 3D 22267

GUDID 04056481000721

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481000721
• NIH Device Record Key: f1be809f-22fc-461f-85fb-cb7aef53e3b5
• Commercial Distribution Discontinuation: 2019-12-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Navigation Software Spine & Trauma 3D
• Version Model Number: 2.1
• Catalog Number: 22267
• 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

Customer Support Contacts

• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481000721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070106

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: 4
• Public Version Date: 2019-12-12
• Device Publish Date: 2016-09-15

On-Brand Devices [Navigation Software Spine & Trauma 3D]

• 04056481106591: 2.6
• 04056481000721: 2.1
• 04056481000714: 2.5