eudamed_udi Primary ID: 09421028115315

Charnley Fixed Blade Lightpipe Spiked Retractor Long (UDI 09421028115315)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Charnley Fixed Blade Lightpipe Spiked Retractor Long (Model/Catalog Number: 35130023) is a medical device manufactured by Enztec Limited. This product is indexed under FDA Product Code / Category Classification L0915 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0612-2020 View Full Alert →

REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE...

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Technical Specifications

Model Number: 35130023
Product Code / EMDN: L0915
Device Name: Retractors and Frames
Database Sync Date: 2026-08-09 16:44:50

Full Regulatory Attributes

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{
    "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 Charnley Fixed Blade Lightpipe Spiked Retractor Long?

The registered manufacturer of record for Charnley Fixed Blade Lightpipe Spiked Retractor Long is Enztec Limited.

What is the Primary UDI-DI identifier for Charnley Fixed Blade Lightpipe Spiked Retractor Long?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09421028115315.

What classification code is assigned to this device?

This device is registered under product classification code L0915.

Similar Classification Devices (L0915)

Other Devices by Enztec Limited

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