Spine & Trauma 3D Navigation

GUDID 04056481142025

Software for spine navigation

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481142025
• NIH Device Record Key: 1275fe46-7c9d-49a5-899d-f8b578d2ecb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spine & Trauma 3D Navigation
• Version Model Number: 1,5
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481142025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183605

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-21
• Device Publish Date: 2020-02-13

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

• 04056481140328: 1.0
• 04056481142025: Software for spine navigation