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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
Nephroscopic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Bougie tube, set, 9-28 Fr. FDA UDI
Model / Reference
WA33027A FDA UDI
Description
Bougie tube, set, 9-28 Fr. FDA UDI

Identifiers

Catalog Number
WA33027A FDA UDI
Primary DI / UDI-DI
04042761051842 FDA UDI
510(k) Number
K853486 FDA UDI
FDA Product Code
FGA FDA UDI
GMDN Term
Nephroscopic surgical procedure kit, non-medicated, 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

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: Nephroscopic surgical procedure kit, non-medicated, reusable

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

Cleared under the same submission

K853486 also covers:

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 639613f2-deae-4519-8212-880fa3c9d401 36 fields · synced May 30, 2026