RT Elements - Multiple Brain Mets SRS

GUDID 04056481140946

Brainlab AG

Radiation therapy software

• Primary Device ID: 04056481140946
• NIH Device Record Key: c6f6c57e-1b8f-4857-a4ec-6d9207285f43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RT Elements - Multiple Brain Mets SRS
• Version Model Number: 2.0
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481140946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170750

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2019-03-07
• Device Publish Date: 2019-02-04

On-Brand Devices [RT Elements - Multiple Brain Mets SRS]

• 04056481140946: 2.0
• 04056481142094: 3.0