Viewer

GUDID 04056481143800

Brainlab AG

Medical image management system

• Primary Device ID: 04056481143800
• NIH Device Record Key: b544656b-1287-4708-bb64-0c19e19fc9d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viewer
• Version Model Number: 5.3
• 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	04056481143800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191014

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: 2022-04-07
• Device Publish Date: 2022-03-30

On-Brand Devices [Viewer]

• 04056481139070: 4.0
• 04056481141776: 5.0
• 04056481142513: 5.1
• 04056481143800: 5.3