WiScope®

GUDID 06972084140061

Image System, adapting to a monitor of 16:9 aspect ratio

Ningbo Wise Optomech Technology Corporation

Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID06972084140061
NIH Device Record Keycfbcc1de-fe9c-4805-bfea-038c966d7fcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameWiScope®
Version Model NumberOTU-A
Company DUNS540094524
Company NameNingbo Wise Optomech Technology Corporation
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106972084140061 [Primary]
GS106972084140061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FGBUreteroscope And Accessories, Flexible/Rigid
FGBUreteroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-19
Device Publish Date2019-08-22

On-Brand Devices [WiScope®]

06972084140054Image System
16972084140044Single-Use Digital Flexible Ureteroscope
16972084140037Single-Use Digital Flexible Ureteroscope
16972084140020Single-Use Digital Flexible Ureteroscope
06972084140016Single-Use Digital Flexible Ureteroscope
16972084140105Single-Use Digital Flexible UroScope
16972084140099Single-Use Digital Flexible UroScope
06972084140085Single-Use Digital Flexible UroScope
16972084140075Single-Use Digital Flexible UroScope
06972084140061Image System, adapting to a monitor of 16:9 aspect ratio

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