URUS System

GUDID 08809921580026

DYNE MEDICAL GROUP Inc

Video image processor
Primary Device ID08809921580026
NIH Device Record Keyaad8d2ee-cd32-4fdf-af08-9aa1b84c34a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameURUS System
Version Model NumberVP-100
Company DUNS963230418
Company NameDYNE MEDICAL GROUP Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809921580026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-19
Device Publish Date2024-12-11

Devices Manufactured by DYNE MEDICAL GROUP Inc

08809921580019 - URUS2024-12-19
08809921580026 - URUS System2024-12-19
08809921580026 - URUS System2024-12-19

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