EXCELSIUS3D

GUDID 00193982184506

Excelsius3D

GLOBUS MEDICAL, INC.

Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00193982184506
• NIH Device Record Key: 54045c5f-954e-4b4c-9817-bcbf2cc8767e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXCELSIUS3D
• Version Model Number: 6161.1000
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00193982184506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210912

FDA Product Code

• OXO: Image-intensified fluoroscopic x-ray system, mobile

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: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [EXCELSIUS3D]

• 00193982184537: Mobile Monitor
• 00193982184506: Excelsius3D