gudid Primary ID: EGA-7011

IRRIGATOR/INSUFFLATOR (UDI EGA-7011)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The IRRIGATOR/INSUFFLATOR (Model/Catalog Number: EGA-7011) is a medical device manufactured by PENTAX OF AMERICA, INC.. This product is indexed under FDA Product Code / Category Classification FCX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: EGA-7011
Product Code / EMDN: FCX
Device Name: HIGH PRESSURE HOSE 3FT, EGA-501P
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 IRRIGATOR/INSUFFLATOR?

The registered manufacturer of record for IRRIGATOR/INSUFFLATOR is PENTAX OF AMERICA, INC..

What is the Primary UDI-DI identifier for IRRIGATOR/INSUFFLATOR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is EGA-7011.

What classification code is assigned to this device?

This device is registered under product classification code FCX.

Similar Classification Devices (FCX)

Other Devices by PENTAX OF AMERICA, INC.

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