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EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE FDA UDI
Generic Name
Flexible video gastroduodenoscope FDA UDI
Device Name
GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI FDA UDI
Model / Reference
OLYMPUS GIF-XP190N FDA UDI
Description
GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI FDA UDI

Identifiers

Primary DI / UDI-DI
04953170305313 FDA UDI
510(k) Number
K123317 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 lll 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

K123317 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 5c732817-cfe8-41ea-befd-5c50cad30113 35 fields · synced May 30, 2026