Monaco

GUDID 07340201500033

Elekta Solutions AB

Radiation therapy software

• Primary Device ID: 07340201500033
• NIH Device Record Key: e7acc749-7478-4dae-8127-fd8b0c20da19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monaco
• Version Model Number: Monaco
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• 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	07340201500033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213787

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: 2022-07-19
• Device Publish Date: 2022-07-11

On-Brand Devices [Monaco]

• 07340201500033: Monaco
• 07340201500064: 6.2