EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V N5992941

GUDID 04953170452024

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video duodenoscope, reusable
Primary Device ID04953170452024
NIH Device Record Keye0e4ccc9-0960-470d-8723-0c643addd416
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Version Model NumberTJF-Q190V
Catalog NumberN5992941
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170452024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDTDuodenoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


[04953170452024]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-09
Device Publish Date2022-06-01

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