GUDIDData
Bulk Audit Tool API Access
eudamed_udi Primary ID: 00851289007064

Unspecified Brand (UDI 00851289007064)

Manufactured by Firefly Global

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 00851289007064

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: DE500) is a medical device manufactured by Firefly Global. This product is indexed under FDA Product Code / Category Classification Z12149006 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
DE500
Product Code / EMDN
Z12149006
Device Name
DE500
Database Sync Date
2026-08-09 17:58:01

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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Firefly Global.

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00851289007064.

What classification code is assigned to this device?

This device is registered under product classification code Z12149006.

Similar Classification Devices (Z12149006)

Other Devices by Firefly Global

Programmatic Export

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JSON API Endpoint