EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE

GUDID 04953170305313

GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope
Primary Device ID04953170305313
NIH Device Record Key5c732817-cfe8-41ea-befd-5c50cad30113
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE
Version Model NumberOLYMPUS GIF-XP190N
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 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
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
GS104953170305313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDSGastroscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


[04953170305313]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE]

04953170305313GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI
04953170436772OLYMPUS GIF-XP190N

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