GUDIDData
pma Primary ID: P070026

CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (UDI P070026)

Manufactured by DePuy Orthopaedics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CERAMAX (R) CERAMIC TOTAL HIP SYSTEM - Primary ID P070026

Device Regulatory Overview

The CERAMAX (R) CERAMIC TOTAL 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 CERAMAX (R) CERAMIC TOTAL HIP SYSTEM?

The registered manufacturer of record for CERAMAX (R) CERAMIC TOTAL HIP SYSTEM is DePuy Orthopaedics, Inc..

What is the Primary UDI-DI identifier for CERAMAX (R) CERAMIC TOTAL HIP SYSTEM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P070026.

What classification code is assigned to this device?

This device is registered under product classification code MRA.

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