gudid Primary ID: 862305001

SOOTHE-GUARD AIR (UDI 862305001)

Manufactured by Dentsply International Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SOOTHE-GUARD AIR (Model/Catalog Number: 862305001) is a medical device manufactured by Dentsply International Inc.. This product is indexed under FDA Product Code / Category Classification IWO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 862305001
Product Code / EMDN: IWO
Device Name: Soothe-Guard Air Adult Apron with Collar .35mm - Charcoal
Database Sync Date: 2026-08-09 09:02:02

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 SOOTHE-GUARD AIR?

The registered manufacturer of record for SOOTHE-GUARD AIR is Dentsply International Inc..

What is the Primary UDI-DI identifier for SOOTHE-GUARD AIR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 862305001.

What classification code is assigned to this device?

This device is registered under product classification code IWO.

Similar Classification Devices (IWO)

Other Devices by Dentsply International Inc.

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