EXCELSIUS3D

GUDID 00193982184537

Mobile Monitor

GLOBUS MEDICAL, INC.

Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00193982184537
• NIH Device Record Key: e8e23669-e5b8-49f8-994a-3d15a46c7d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXCELSIUS3D
• Version Model Number: 6161.2100
• 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	00193982184537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210912

FDA Product Code

• OWB: Interventional fluoroscopic x-ray system

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