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Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name
Olympus FDA UDI
Generic Name
Endoscope working-channel valve, single-use FDA UDI
Device Name
Sealing cap, for 5 Fr., 3-ply lamella, 10 pieces FDA UDI
Model / Reference
A0313 FDA UDI
Description
Sealing cap, for 5 Fr., 3-ply lamella, 10 pieces FDA UDI

Identifiers

Catalog Number
A0313 FDA UDI
Primary DI / UDI-DI
14042761001417 FDA UDI
FDA Product Code
GCP FDA UDI
GMDN Term
Endoscope working-channel valve, single-use 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscope working-channel valve, single-use

Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope working-channel valve, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA UDI a043f410-8dec-4ab9-a079-1fba9c941691 35 fields · synced May 30, 2026