Brainlab Elements Contouring

GUDID 04056481143015

Brainlab AG

Stereotactic system application software

• Primary Device ID: 04056481143015
• NIH Device Record Key: f91ce2e2-f047-403b-b404-77c0c67d4df1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brainlab Elements Contouring
• Version Model Number: 4.0
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481143015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212420

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: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [Brainlab Elements Contouring]

• 04056481143015: 4.0
• 04056481144623: 4.5