URUS

GUDID 08809921580019

DYNE MEDICAL GROUP Inc

Flexible video ureteroscope, single-use

• Primary Device ID: 08809921580019
• NIH Device Record Key: 6eae2e4a-0523-4d20-807e-2403cb6fb663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URUS
• Version Model Number: DMG-SU100
• Company DUNS: 963230418
• Company Name: DYNE MEDICAL GROUP 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	08809921580019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240203

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-19
• Device Publish Date: 2024-12-11

Devices Manufactured by DYNE MEDICAL GROUP Inc

• 08809921580019 - URUS: 2024-12-19
• 08809921580019 - URUS: 2024-12-19
• 08809921580026 - URUS System: 2024-12-19