GUDIDData
eudamed_udi Primary ID: 05907514694129

OS-LDL DIRECT (UDI 05907514694129)

Manufactured by PZ CORMAY Spółka Akcyjna

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OS-LDL DIRECT - Primary ID 05907514694129

Device Regulatory Overview

The OS-LDL DIRECT (Model/Catalog Number: 9-412) is a medical device manufactured by PZ CORMAY Spółka Akcyjna. This product is indexed under FDA Product Code / Category Classification W01010221 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
9-412
Product Code / EMDN
W01010221
Device Name
LDL DIRECT
Database Sync Date
2026-08-09 16:51:57

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 OS-LDL DIRECT?

The registered manufacturer of record for OS-LDL DIRECT is PZ CORMAY Spółka Akcyjna.

What is the Primary UDI-DI identifier for OS-LDL DIRECT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05907514694129.

What classification code is assigned to this device?

This device is registered under product classification code W01010221.

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