COLONOVIDEOSCOPE

GUDID 04953170334184

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable
Primary Device ID04953170334184
NIH Device Record Keybbb95024-8346-4ab0-a755-3cbaeb6e2b2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOLONOVIDEOSCOPE
Version Model NumberCF-H170I
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170334184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

High-level Disinfectant;Ethylene Oxide


[04953170334184]

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 [COLONOVIDEOSCOPE]

04953170334184CF-H170I
04953170334160CF-H170L
04953170312410OLYMPUS CF-LV1I
04953170312397OLYMPUS CF-LV1L
04953170307638CF-Q150L
04953170307621CF-Q150I
04953170229473CF-Q150I
04953170229466CF-Q150L
04953170424298OLYMPUS CF-HQ1100DI
04953170424281OLYMPUS CF-HQ1100DL

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