EVIS EXERA II COLONOVIDEOSCOPE

GUDID 04953170202315

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable
Primary Device ID04953170202315
NIH Device Record Key4d334b53-b72c-4fa7-9f3d-58cecc264c0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA II COLONOVIDEOSCOPE
Version Model NumberOLYMPUS CF TYPE Q180AL
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
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
GS104953170202315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWBEndoscope, accessories, narrow band spectrum

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


[04953170202315]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-08
Device Publish Date2016-09-21

On-Brand Devices [EVIS EXERA II COLONOVIDEOSCOPE]

04953170339905"PCF-H180AL EVIS EXERA II COLONOSCOPE"
04953170339899OLYMPUS PCF TYPE H180AL
04953170339882"PCF-H180AI EVIS EXERA II ULTRA THIN CLNV"
04953170339875OLYMPUS PCF TYPE H180AI
04953170339653CF-H180DL EVIS EXERA II COLONOSCOPE
04953170339639OLYMPUS CF TYPE H180DI
04953170339615CF-H180AL EVIS EXERA II HD COLONOSCOPE
04953170339608OLYMPUS CF TYPE H180AL
04953170339592CF-H180AI EVIS EXERA II HD COLONOSCOPE
04953170339585OLYMPUS CF TYPE H180AI
04953170339189"PCF-Q180AL EVIS EXERA II COLONOSCOPE"
04953170339172"PCF-Q180AI EVIS EXERA II COLONOSCOPE"
04953170307720OLYMPUS PCF TYPE Q180AL
04953170307713OLYMPUS PCF TYPE Q180AI
04953170307706OLYMPUS CF TYPE Q180AL
04953170307690OLYMPUS CF TYPE Q180AI
04953170237300OLYMPUS PCF TYPE H180AI
04953170237294OLYMPUS PCF TYPE H180AL
04953170237287OLYMPUS PCF TYPE H180AL
04953170202544OLYMPUS PCF TYPE Q180AL
04953170202506OLYMPUS CF TYPE H180AI
04953170202445OLYMPUS CF TYPE H180AL
04953170202339OLYMPUS CF TYPE H180AL
04953170202315OLYMPUS CF TYPE Q180AL

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