Brainlab Elements Image Fusion

GUDID 04056481143992

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