WiScope® 4201A0301T

GUDID 00850023925107

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

Otu Medical Inc.

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID00850023925107
NIH Device Record Key16935ce0-c482-4ffb-801f-c29288701ad9
Commercial Distribution StatusIn Commercial Distribution
Brand NameWiScope®
Version Model NumberOTU-A
Catalog Number4201A0301T
Company DUNS100796993
Company NameOtu Medical 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850023925107 [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 Date2021-04-26
Device Publish Date2021-04-17

On-Brand Devices [WiScope®]

10850023925159Single-Use Digital Flexible UroScope
00850023925145Single-Use Digital Flexible Uroscope
00850023925138Single-Use Digital Flexible UroScope
10850023925128Single-Use Digital Flexible UroScope
00850023925114Image System, adapting to a monitor of 16:9 aspect ratio.
00850023925107Image System, adapting to a monitor of 16:9 aspect ratio.
00850023925091Image System, adapting to a monitor of 4:3 aspect ratio.
00850023925084Image System, adapting to a monitor of 4:3 aspect ratio.
10850023925074Single-Use Digital Flexible Ureteroscope
10850023925067Single-Use Digital Flexible Ureteroscope
10850023925050Single-Use Digital Flexible Ureteroscope
10850023925043Single-Use Digital Flexible Ureteroscope
10850023925197Single-Use Digital Flexible Cystoscope
10850023925180Single-Use Digital Flexible Cystoscope
10850023925173Single-Use Digital Flexible Cystoscope
10850023925166Single-Use Digital Flexible Cystoscope
00850023925282Image System, adapting to a monitor of 16:9 aspect ratio
10850023925302Single-Use Digital Flexible Ureteroscope/Choledochoscope
10850023925296Single-Use Digital Flexible Ureteroscope/Choledochoscope
10850023925265Single-Use Digital Flexible Ureteroscope/Choledochoscope
10850023925258Single-Use Digital Flexible Ureteroscope/Choledochoscope
10850023925241Single-Use Digital Flexible Ureteroscope/Choledochoscope
10850023925234Single-Use Digital Flexible Ureteroscope/Choledochoscope
10850023925227Single-Use Digital Flexible Bronchoscope
10850023925210Single-Use Digital Flexible Bronchoscope
10850023925203Single-Use Digital Flexible Bronchoscope
00850023925343Image System
10850023925333Single-Use Digital Flexible Ureteroscope
10850023925326Single-Use Digital Flexible Ureteroscope
00850023925312Image System

Trademark Results [WiScope]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WISCOPE
WISCOPE
88407180 not registered Live/Pending
Inspectron, Inc.
2019-04-29
WISCOPE
WISCOPE
87636989 5571987 Live/Registered
OTU MEDICAL INC.
2017-10-06

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