URUS System

Basic Information

• Brand Name: URUS System
• Primary DI: 08809921580026
• Version / Model: VP-100
• Company Name: DYNE MEDICAL GROUP Inc
• Labeler DUNS: 963230418
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-11
• Public Version: 1
• Public Version Date: 2024-12-19
• Public Version Status: New
• Public Device Record Key: aad8d2ee-cd32-4fdf-af08-9aa1b84c34a6

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36947	Video image processor	A mains electricity (AC-powered) device designed to receive the electronic signals sent from a video camera for the purpose of editing and processing them into images. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images will typically be, e.g., a video recording of a magnetic resonance imaging (MRI) examination. Other forms of recording media may be used.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809921580026	GS1

Premarket Submissions

Submission Number	Supplement Number
K240203	000