GASTROINTESTINAL VIDEOSCOPE N6019440

GUDID 04953170420191

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope Flexible video gastroduodenoscope
Primary Device ID04953170420191
NIH Device Record Keye0b5db5b-4c20-485a-bb29-e14bb74fc9fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGASTROINTESTINAL VIDEOSCOPE
Version Model NumberOLYMPUS GIF-1100
Catalog NumberN6019440
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 Perscriptionfalse
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
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170420191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


[04953170420191]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-12
Device Publish Date2023-07-04

On-Brand Devices [GASTROINTESTINAL VIDEOSCOPE]

04953170334115GIF-H170
04953170307485GIF-Q150
04953170307478GIF-XP150N
04953170229442GIF-XP150N
04953170229435GIF-Q150
04953170420191OLYMPUS GIF-1100

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