Unipack (UDI UBC-8048)

Manufactured by Dukal LLC

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Unipack (Model/Catalog Number: UBC-8048) is a medical device manufactured by Dukal LLC. This product is indexed under FDA Product Code / Category Classification PEM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: UBC-8048
Product Code / EMDN: PEM
Device Name: Barrier Film 4" x 6" 1200 sheets/roll Blue
Database Sync Date: 2026-08-09 09:05:54

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 Unipack?

The registered manufacturer of record for Unipack is Dukal LLC.

What is the Primary UDI-DI identifier for Unipack?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is UBC-8048.

What classification code is assigned to this device?

This device is registered under product classification code PEM.

Similar Classification Devices (PEM)

Other Devices by Dukal LLC

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