EU-Scope

GUDID 06970034210345

Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed D

SHANGHAI ANQING MEDICAL INSTRUMENT CO.,LTD.

Flexible video ureteroscope, reusable
Primary Device ID06970034210345
NIH Device Record Keyf744e140-6da3-43dc-8164-624c282a1509
Commercial Distribution StatusIn Commercial Distribution
Brand NameEU-Scope
Version Model NumberUS31B-12
Company DUNS544581269
Company NameSHANGHAI ANQING MEDICAL INSTRUMENT CO.,LTD.
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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970034210345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-08
Device Publish Date2019-01-10

Devices Manufactured by SHANGHAI ANQING MEDICAL INSTRUMENT CO.,LTD.

06970034210147 - DOS2019-03-08 The video processor is used with the Single Use Flexible Ureterorenoscope designed by ANQING during minimally invasive surgery.
06970034210345 - EU-Scope2019-03-08Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed D
06970034210345 - EU-Scope2019-03-08 Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be us
06970034210352 - DOS2019-03-08 The video processor is used with the Single Use Flexible Ureterorenoscope designed by ANQING during minimally invasive surgery.
06970034210130 - EU-Scope2019-03-07 Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be us

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