ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE N3828133

GUDID 04953170434662

OLYMPUS MEDICAL SYSTEMS CORP.

Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope
Primary Device ID04953170434662
NIH Device Record Key33c451d3-b64d-4d60-bf13-213f641d4757
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Version Model NumberOLYMPUS LTF-S190-10
Catalog NumberN3828133
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 Latexfalse
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
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170434662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


[04953170434662]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-28
Device Publish Date2023-04-20

On-Brand Devices [ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE]

04953170310386LTF-S190-10 ENDOEYE FLEX 10 VIDEOSCOPE
04953170310355LTF-S190-5 ENDOEYE FLEX 5 HD VIDEOSCOPE
04953170434662OLYMPUS LTF-S190-10
04953170434648OLYMPUS LTF-S190-5

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