GUDIDData
gudid Primary ID: 28203

NA (UDI 28203)

Manufactured by Zimmer, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NA - Primary ID 28203

Device Regulatory Overview

The NA (Model/Catalog Number: 28203) is a medical device manufactured by Zimmer, Inc.. This product is indexed under FDA Product Code / Category Classification ELM 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-2578-2026 View Full Alert →

Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 ...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2529-2026 View Full Alert →

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2531-2026 View Full Alert →

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476...

🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
28203
Product Code / EMDN
ELM
Device Name
TRIBOS 501 Kunststoffzaehne VR14-OK-A3
Database Sync Date
2026-08-09 09:08:31

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 NA?

The registered manufacturer of record for NA is Zimmer, Inc..

What is the Primary UDI-DI identifier for NA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 28203.

What classification code is assigned to this device?

This device is registered under product classification code ELM.

Programmatic Export

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