Brainlab Elements SmartBrush

GUDID 04056481142162

Brainlab AG

Radiology PACS software

• Primary Device ID: 04056481142162
• NIH Device Record Key: 45fdce9b-2bca-4ac1-952f-f9fb462dc51f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brainlab Elements SmartBrush
• Version Model Number: 3.0
• 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: true
• 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	04056481142162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113732

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [Brainlab Elements SmartBrush]

• 04056481140670: 2.6
• 04056481142162: 3.0