gudid Primary ID: EBT-XD MAX-EA Ortho Film 1 @8SH

Gafchromic (UDI EBT-XD MAX-EA Ortho Film 1 @8SH)

Manufactured by ASHLAND SPECIALTY INGREDIENTS G.P.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Gafchromic (Model/Catalog Number: EBT-XD MAX-EA Ortho Film 1 @8SH) is a medical device manufactured by ASHLAND SPECIALTY INGREDIENTS G.P.. This product is indexed under FDA Product Code / Category Classification IWZ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: EBT-XD MAX-EA Ortho Film 1 @8SH
Product Code / EMDN: IWZ
Device Name
Database Sync Date: 2026-08-09 09:09:51

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 Gafchromic?

The registered manufacturer of record for Gafchromic is ASHLAND SPECIALTY INGREDIENTS G.P..

What is the Primary UDI-DI identifier for Gafchromic?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is EBT-XD MAX-EA Ortho Film 1 @8SH.

What classification code is assigned to this device?

This device is registered under product classification code IWZ.

Similar Classification Devices (IWZ)

Other Devices by ASHLAND SPECIALTY INGREDIENTS G.P.

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