gudid Primary ID: OS-A116

PENTAX Medical (UDI OS-A116)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The PENTAX Medical (Model/Catalog Number: OS-A116) is a medical device manufactured by HOYA CORPORATION. This product is indexed under FDA Product Code / Category Classification PEA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: OS-A116
Product Code / EMDN: PEA
Device Name: PENTAX Medical Keyboard EN OS-A116
Database Sync Date: 2026-08-09 09:46:01

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of PENTAX Medical?

The registered manufacturer of record for PENTAX Medical is HOYA CORPORATION.

What is the Primary UDI-DI identifier for PENTAX Medical?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OS-A116.

What classification code is assigned to this device?

This device is registered under product classification code PEA.

Similar Classification Devices (PEA)

Other Devices by HOYA CORPORATION

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