Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name: Olympus FDA UDI
Generic Name: Endoscope sheath, reusable FDA UDI
Device Name: Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS FDA UDI
Model / Reference: A42011A FDA UDI
Description: Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS FDA UDI

Identifiers

Catalog Number: A42011A FDA UDI
Primary DI / UDI-DI: 04042761023658 FDA UDI
510(k) Number: K931994 FDA UDI
K931995 FDA UDI
FDA Product Code: FJL FDA UDI
HIH FDA UDI
GMDN Term: Endoscope sheath, reusable 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

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endoscope sheath, reusable

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

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Cleared under the same submission

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 37af1bc1-1c85-424c-a55d-7b443a1227ff 36 fields · synced May 30, 2026