Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name: Olympus FDA UDI
Generic Name: Endoscopic biopsy valve, sterile FDA UDI
Model / Reference: WA00387A FDA UDI

Identifiers

Catalog Number: WA00387A FDA UDI
Primary DI / UDI-DI: 14042761062968 FDA UDI
FDA Product Code: GEI FDA UDI
GCP FDA UDI
GMDN Term: Endoscopic biopsy valve, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic biopsy valve, sterile

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

Similar devices

Also classified as Endoscopic biopsy valve, sterile.

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Disposable Biopsy Valve — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
Disposable Biopsy Valve — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
Andorate — Smartdata Suzhou Co., Ltd. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Olympus Winter & Ibe GmbH

Sources (1)

FDA UDI e2010bcf-225a-404f-aafc-9d5ad78da146 34 fields · synced May 30, 2026