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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
Laparoscopic trocar blade, reusable FDA UDI
Device Name
Trocar spike, 11 x 60 mm, blunt FDA UDI
Model / Reference
WA58365S FDA UDI
Description
Trocar spike, 11 x 60 mm, blunt FDA UDI

Identifiers

Catalog Number
WA58365S FDA UDI
Primary DI / UDI-DI
04042761030779 FDA UDI
510(k) Number
K923982 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic trocar blade, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
Not 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

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

Cleared under the same submission

K923982 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 0792cbd6-4afb-4261-ae8d-9cbd1a946648 37 fields · synced Jun 1, 2026