WiScope® 4101U0201T

GUDID 10850023925050

Single-Use Digital Flexible Ureteroscope

Otu Medical Inc.

Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use Flexible video ureteroscope, single-use
Primary Device ID10850023925050
NIH Device Record Key9555201b-dddf-45ef-9fd5-089316f56690
Commercial Distribution StatusIn Commercial Distribution
Brand NameWiScope®
Version Model NumberOTU-100RR
Catalog Number4101U0201T
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100850023925053 [Primary]
GS110850023925050 [Package]
Contains: 00850023925053
Package: [10 Units]
Discontinued: 2021-04-17
Not in Commercial Distribution

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 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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