eudamed_udi Primary ID: 09421028113403

Enztec MIH Hohmann Narrow Retractor (UDI 09421028113403)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Enztec MIH Hohmann Narrow Retractor (Model/Catalog Number: 4050-0003) 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: 4050-0003
Product Code / EMDN: L0915
Device Name: Retractors and Frames
Database Sync Date: 2026-08-09 16:29:14

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 Enztec MIH Hohmann Narrow Retractor?

The registered manufacturer of record for Enztec MIH Hohmann Narrow Retractor is Enztec Limited.

What is the Primary UDI-DI identifier for Enztec MIH Hohmann Narrow Retractor?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09421028113403.

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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