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Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name
PENTAX FDA UDI
Generic Name
Luer/non-ISO80369-standardized linear connector, reusable FDA UDI
Device Name
AIR CLEANING BRUSH ADAPTER FDA UDI
Model / Reference
OF-B170 FDA UDI
Description
AIR CLEANING BRUSH ADAPTER FDA UDI

Identifiers

Primary DI / UDI-DI
04961333076420 FDA UDI
510(k) Number
K961564 FDA UDI
FDA Product Code
FDS FDA UDI
GMDN Term
Luer/non-ISO80369-standardized linear connector, 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

Category: Luer/non-ISO80369-standardized linear connector, reusable

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

Similar devices

Also classified as Luer/non-ISO80369-standardized linear connector, reusable.

Cleared under the same submission

K961564 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hoya Corporation

Sources (1)

  • FDA UDI 02ab8012-bec6-43c7-83cb-44060920cbd7 34 fields · synced May 30, 2026