Brainlab Elements Image Fusion

GUDID 04056481143992

Brainlab AG

Stereotactic system application software

• Primary Device ID: 04056481143992
• NIH Device Record Key: dc09b243-1185-4035-8281-8b78366c9d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brainlab Elements Image Fusion
• Version Model Number: 4.5
• 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	04056481143992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223106

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [Brainlab Elements Image Fusion]

• 04056481140816: 4.0
• 04056481143992: 4.5