GUDIDData
pma Primary ID: P040023

DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (UDI P040023)

Manufactured by DePuy Orthopaedics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM - Primary ID P040023

Device Regulatory Overview

The DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (Model/Catalog Number: Unspecified) is a medical device manufactured by DePuy Orthopaedics, Inc.. This product is indexed under FDA Product Code / Category Classification MRA within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1456-2024 View Full Alert →

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ID: Z-1375-2022 View Full Alert →

MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 1...

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ID: Z-0590-2013 View Full Alert →

SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. T...

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Technical Specifications

Model Number
N/A
Product Code / EMDN
MRA
Device Name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Database Sync Date
2026-08-09 10:04:45

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 DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM?

The registered manufacturer of record for DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM is DePuy Orthopaedics, Inc..

What is the Primary UDI-DI identifier for DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P040023.

What classification code is assigned to this device?

This device is registered under product classification code MRA.

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