Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name: PENTAX FDA UDI
Generic Name: Device control handling knob FDA UDI
Device Name: Suction Channel Selector OF-B161 FDA UDI
Model / Reference: OF-B161 FDA UDI
Description: Suction Channel Selector OF-B161 FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333077731 FDA UDI
510(k) Number: K131902 FDA UDI
FDA Product Code: FDS FDA UDI
GMDN Term: Device control handling knob 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

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

Category: Device control handling knob

Pentax by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K131902 also covers:

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: Hoya Corporation

Sources (1)

FDA UDI fa31a433-ab34-4a65-9cc7-cd00487fd41b 34 fields · synced May 30, 2026