GUDIDData
gudid Primary ID: Standard

AcuityPDR (UDI Standard)

Manufactured by RADMEDIX, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AcuityPDR - Primary ID Standard

Device Regulatory Overview

The AcuityPDR (Model/Catalog Number: Standard) is a medical device manufactured by RADMEDIX, LLC. This product is indexed under FDA Product Code / Category Classification IZL within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Standard
Product Code / EMDN
IZL
Device Name
Database Sync Date
2026-08-09 09:17:03

Full Regulatory Attributes

🔒 Token Gated
{
    "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 AcuityPDR?

The registered manufacturer of record for AcuityPDR is RADMEDIX, LLC.

What is the Primary UDI-DI identifier for AcuityPDR?

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

What classification code is assigned to this device?

This device is registered under product classification code IZL.

Programmatic Export

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JSON API Endpoint