Brainlab Elements Contouring

GUDID 04056481143015

Brainlab AG

Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software 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