EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 N5367140

GUDID 04953170467356

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible ultrasound gastroduodenoscope
Primary Device ID04953170467356
NIH Device Record Keyf3546575-eb86-4b02-a308-3e329028bbac
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180
Version Model NumberGF-UCT180
Catalog NumberN5367140
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170467356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170467356]

Ethylene Oxide


[04953170467356]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-03
Device Publish Date2025-09-25

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

04953170467325 - SUCTION VALVE MAJ-14432025-10-03
04953170467332 - AIR/WATER VALVE MAJ-14442025-10-03
04953170467349 - ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL52025-10-03
04953170467356 - EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT1802025-10-03
04953170467356 - EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT1802025-10-03
04953170467295 - ULTRASONIC PROBE2025-09-26
04953170467301 - ULTRASONIC PROBE2025-09-26
14953170458375 - Single Use Aspiration Needle NA-201SX-40212025-08-22
14953170458382 - Single Use Aspiration Needle2025-08-22

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