ULTRASONIC GASTROVIDEOSCOPE

GUDID 04953170062797

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible ultrasound gastroduodenoscope
Primary Device ID04953170062797
NIH Device Record Key6137f468-0d1d-4699-a883-da69be59a286
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRASONIC GASTROVIDEOSCOPE
Version Model NumberOLYMPUS GF TYPE UCT140-AL5
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170062797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


[04953170062797]

High-level Disinfectant;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-28
Device Publish Date2021-12-20

On-Brand Devices [ULTRASONIC GASTROVIDEOSCOPE]

04953170356322GF-UC140P-AL5 CLA EUS scope, 2.8mm chan
04953170356261GF-UE160-AL5 Radial array EUS scope
04953170355448OLYMPUS GF TYPE UC140P-AL5
04953170355431OLYMPUS GF TYPE UC140P-AL5
04953170355349OLYMPUS GF TYPE UE160-AL5
04953170341748OLYMPUS GF TYPE UC140P-AL5
04953170310546OLYMPUS GF TYPE UE160-AL5
04953170203107OLYMPUS GF TYPE UE160-AL5
04953170167638OLYMPUS GF TYPE UC140P-AL5
04953170062803OLYMPUS GF TYPE UC140P-AL5
04953170062797OLYMPUS GF TYPE UCT140-AL5

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