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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
Argon-enhanced electrosurgical system gas delivery unit FDA UDI
Device Name
Pressure reducer with connector acc. to CGA No. 580, for Argon Plasma Coagulation FDA UDI
Model / Reference
WA94043A FDA UDI
Description
Pressure reducer with connector acc. to CGA No. 580, for Argon Plasma Coagulation FDA UDI

Identifiers

Catalog Number
WA94043A FDA UDI
Primary DI / UDI-DI
04042761083591 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Argon-enhanced electrosurgical system gas delivery unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Category: Argon-enhanced electrosurgical system gas delivery unit

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

Similar devices

Also classified as Argon-enhanced electrosurgical system gas delivery unit.

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 d65f6157-be7d-4c47-83a8-779d69735893 35 fields · synced Jun 8, 2026