gudid Primary ID: Endo Leak Tester Kit-4010841

NA (UDI Endo Leak Tester Kit-4010841)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The NA (Model/Catalog Number: Endo Leak Tester Kit-4010841) is a medical device manufactured by MEDIVATORS INC.. This product is indexed under FDA Product Code / Category Classification FCY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Endo Leak Tester Kit-4010841
Product Code / EMDN: FCY
Device Name: Endo Leak Kit contains Endo Leak Tester, Wolf Adapter, Calibration Adapter, Calibration Gauge, and power supply.
Database Sync Date: 2026-08-09 09:19:08

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 NA?

The registered manufacturer of record for NA is MEDIVATORS INC..

What is the Primary UDI-DI identifier for NA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Endo Leak Tester Kit-4010841.

What classification code is assigned to this device?

This device is registered under product classification code FCY.

Similar Classification Devices (FCY)

Other Devices by MEDIVATORS INC.

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