Monaco

GUDID 00858164002152

ELEKTA, INC.

Radiation therapy software

• Primary Device ID: 00858164002152
• NIH Device Record Key: 8f7c5163-3d11-414d-9aa7-ff766d0e88ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monaco
• Version Model Number: Monaco
• Company DUNS: 079089435
• Company Name: ELEKTA, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858164002152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151233

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-05
• Device Publish Date: 2016-12-06

On-Brand Devices [Monaco]

• 00858164002244: Monaco
• 00858164002190: Monaco
• 00858164002183: Monaco
• 00858164002169: Monaco
• 00858164002152: Monaco
• 00858164002046: Monaco
• 00858164002268: Monaco
• 00858164002275: Monaco