EVIS EXERA COLONOVIDEOSCOPE

GUDID 04953170307652

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable
Primary Device ID04953170307652
NIH Device Record Keyd4c153e4-115f-4c82-b97d-1e28580840f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA COLONOVIDEOSCOPE
Version Model NumberOLYMPUS CF TYPE 2T160L
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170307652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FETEndoscopic video imaging system/component, gastroenterology-urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

Ethylene Oxide;High-level Disinfectant


[04953170307652]

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 COLONOVIDEOSCOPE]

04953170339127CF-2T160L THERAPEUTIC VIDEO COLONOSCOPE
04953170307652OLYMPUS CF TYPE 2T160L
04953170307645OLYMPUS CF TYPE 2T160I
04953170162183OLYMPUS CF TYPE 2T160L
04953170067495OLYMPUS CF TYPE Q160ZL
04953170066986OLYMPUS CF TYPE 2T160L

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