gudid Primary ID: 3004OTCB2XL

HCS Sourcing (UDI 3004OTCB2XL)

Manufactured by Concordance Healthcare Solutions LLC

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

Scannable UDI-DI Representation

Device Regulatory Overview

The HCS Sourcing (Model/Catalog Number: 3004OTCB2XL) is a medical device manufactured by Concordance Healthcare Solutions LLC. This product is indexed under FDA Product Code / Category Classification OEA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 3004OTCB2XL
Product Code / EMDN: OEA
Device Name: Gown, Isolation XL, AAMI Rated Level 2, Yellow. SMS Material, Over the Head Neck, Waist Tie and Thumbloop Cuff
Database Sync Date: 2026-08-09 09:12:22

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 HCS Sourcing?

The registered manufacturer of record for HCS Sourcing is Concordance Healthcare Solutions LLC.

What is the Primary UDI-DI identifier for HCS Sourcing?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 3004OTCB2XL.

What classification code is assigned to this device?

This device is registered under product classification code OEA.

Similar Classification Devices (OEA)

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