gudid Primary ID: Goggle face cushion kit

Otometrics (UDI Goggle face cushion kit)

Manufactured by Natus Medical Denmark ApS

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Otometrics (Model/Catalog Number: Goggle face cushion kit) is a medical device manufactured by Natus Medical Denmark ApS. This product is indexed under FDA Product Code / Category Classification GWN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Goggle face cushion kit
Product Code / EMDN: GWN
Device Name
Database Sync Date: 2026-08-09 09:12:40

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 Otometrics?

The registered manufacturer of record for Otometrics is Natus Medical Denmark ApS.

What is the Primary UDI-DI identifier for Otometrics?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Goggle face cushion kit.

What classification code is assigned to this device?

This device is registered under product classification code GWN.

Similar Classification Devices (GWN)

Other Devices by Natus Medical Denmark ApS

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