Navigation Software Spine & Trauma 3D 22268

GUDID 04056481000714

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481000714
• NIH Device Record Key: 2320c24b-2238-47b0-9b30-1879e7d096d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Software Spine & Trauma 3D
• Version Model Number: 2.5
• Catalog Number: 22268
• 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	04056481000714 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

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

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