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Evis Exera Iii Gastrointestinal Videoscope

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FDA UDI
Generic Name
Flexible video gastroduodenoscope FDA UDI
Device Name
GIF-1TH190 GIF-1TH190 EVIS EXERA III HIG FDA UDI
Model / Reference
OLYMPUS GIF-1TH190 FDA UDI
Description
GIF-1TH190 GIF-1TH190 EVIS EXERA III HIG FDA UDI

Identifiers

Catalog Number
N4505840 FDA UDI
Primary DI / UDI-DI
04953170343360 FDA UDI
510(k) Number
K232997 FDA UDI
FDA Product Code
FDS FDA UDI
NWB FDA UDI
GMDN Term
Flexible video gastroduodenoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible video gastroduodenoscope

Evis Exera Iii Gastrointestinal Videoscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video gastroduodenoscope.

Cleared under the same submission

K232997 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 4d2a41f5-6b42-43c7-8df9-2409df164c84 36 fields · synced Jun 8, 2026