EVIS EXERA III COLONOVIDEOSCOPE

GUDID 04953170416132

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable Flexible video colonoscope, reusable
Primary Device ID04953170416132
NIH Device Record Key601f23b5-25e4-43bb-9f2c-fc95c1a0ff96
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA III COLONOVIDEOSCOPE
Version Model NumberOLYMPUS PCF-HQ190I
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170416132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope and accessories, flexible/rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


[04953170416132]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [EVIS EXERA III COLONOVIDEOSCOPE]

04953170363696OLYMPUS PCF-H190DI
04953170363672OLYMPUS PCF-H190DL
04953170420719OLYMPUS PCF-H190TI
04953170420702OLYMPUS PCF-H190TL
04953170416132OLYMPUS PCF-HQ190I
04953170416118OLYMPUS PCF-HQ190L

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