Elements Image Fusion 26217-02B

GUDID 04056481000356

Brainlab AG

Radiology picture archiving and communication system workstation

• Primary Device ID: 04056481000356
• NIH Device Record Key: be8c7324-f7e8-4040-b430-c9c66d6f8d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elements Image Fusion
• Version Model Number: 2.0
• Catalog Number: 26217-02B
• 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	04056481000356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093117

FDA Product Code

• LLZ: System, Image Processing, Radiological

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 [Elements Image Fusion]

• 04056481006846: 26217-02D
• 04056481000363: 1
• 04056481000356: 2.0