DUODENOVIDEOSCOPE

GUDID 04953170307553

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable Flexible video duodenoscope, reusable
Primary Device ID04953170307553
NIH Device Record Keydebe0f69-9a77-45f4-a189-6ac89e7a7717
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUODENOVIDEOSCOPE
Version Model NumberTJF-150
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exempttrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170307553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


[04953170307553]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-09-21

On-Brand Devices [DUODENOVIDEOSCOPE]

04953170307553TJF-150
04953170229459TJF-150

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