GUDIDData
gudid Primary ID: 33501-41-000

GEN2 (UDI 33501-41-000)

Manufactured by SURGIX MEDICAL LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GEN2 - Primary ID 33501-41-000

Device Regulatory Overview

The GEN2 (Model/Catalog Number: 33501-41-000) is a medical device manufactured by SURGIX MEDICAL LLC. This product is indexed under FDA Product Code / Category Classification JEA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
33501-41-000
Product Code / EMDN
JEA
Device Name
FusionMax Clear Plastic Face Plate
Database Sync Date
2026-08-09 09:07:53

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 GEN2?

The registered manufacturer of record for GEN2 is SURGIX MEDICAL LLC.

What is the Primary UDI-DI identifier for GEN2?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 33501-41-000.

What classification code is assigned to this device?

This device is registered under product classification code JEA.

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