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Evis Exera Ii Colonovideoscope

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
EVIS EXERA II COLONOVIDEOSCOPE FDA UDI
Generic Name
Flexible video colonoscope, reusable FDA UDI
Device Name
"PCF-H180AL EVIS EXERA II COLONOSCOPE" FDA UDI
Model / Reference
OLYMPUS PCF TYPE H180AL FDA UDI
Description
"PCF-H180AL EVIS EXERA II COLONOSCOPE" FDA UDI

Identifiers

Primary DI / UDI-DI
04953170339905 FDA UDI
510(k) Number
K100584 FDA UDI
FDA Product Code
FDF FDA UDI
FDS FDA UDI
NWB FDA UDI
GMDN Term
Flexible video colonoscope, reusable 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 colonoscope, reusable

Evis Exera Ii Colonovideoscope by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video colonoscope, reusable.

Cleared under the same submission

K100584 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 83c2b3e4-7430-466c-8317-50ca84a9e50d 35 fields · synced May 31, 2026