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Pentax

FDA UDI

Class II (US FDA UDI)

by Hoya Corporation

Identity

Trade Name
PENTAX FDA UDI
Generic Name
Endoscope calibration cover, reusable FDA UDI
Device Name
Withe Balance Adjuster OS-A43 FDA UDI
Model / Reference
OS-A43 FDA UDI
Description
Withe Balance Adjuster OS-A43 FDA UDI

Identifiers

Primary DI / UDI-DI
04961333075157 FDA UDI
510(k) Number
K231249 FDA UDI
FDA Product Code
PEA FDA UDI
FDS FDA UDI
FDF FDA UDI
GMDN Term
Endoscope calibration cover, 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
Ethylene Oxide FDA UDI

Category: Endoscope calibration cover, reusable

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

Similar devices

Also classified as Endoscope calibration cover, reusable.

Cleared under the same submission

K231249 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 a7548318-c295-47cc-9760-1300cf046292 34 fields · synced Jun 8, 2026