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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
Stopcock FDA UDI
Model / Reference
WA47778A FDA UDI

Identifiers

Catalog Number
WA47778A FDA UDI
Primary DI / UDI-DI
04042761085939 FDA UDI
510(k) Number
K200369 FDA UDI
K213207 FDA UDI
FDA Product Code
FGB FDA UDI
HIH FDA UDI
GMDN Term
Stopcock FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
884.1690 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Stopcock

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

Similar devices

Also classified as Stopcock.

Cleared under the same submission

K213207 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 13e8539a-52ff-4885-a428-b0aece9eeb09 35 fields · synced Jun 6, 2026