COLONOVIDEOSCOPE N6022540

GUDID 04953170425158

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video colonoscope, reusable
Primary Device ID04953170425158
NIH Device Record Keyf3a3f8de-25f5-42ba-b19c-3309d6e21a3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOLONOVIDEOSCOPE
Version Model NumberOLYMPUS CF-EZ1500D SERIES
Catalog NumberN6022540
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170425158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


[04953170425158]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-03
Device Publish Date2025-05-26

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
04953170425158OLYMPUS CF-EZ1500D SERIES
04953170425103OLYMPUS CF-EZ1500D SERIES

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.