eudamed_udi Primary ID: 07613327311914

Unspecified Brand (UDI 07613327311914)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: 5450-800-278) is a medical device manufactured by Stryker Instruments. This product is indexed under FDA Product Code / Category Classification Z12011399 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-1478-2022 View Full Alert →

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures....

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Technical Specifications

Model Number: 5450-800-278
Product Code / EMDN: Z12011399
Device Name: Sterilization and Assembly Tray
Database Sync Date: 2026-08-09 16:50:57

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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Stryker Instruments.

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07613327311914.

What classification code is assigned to this device?

This device is registered under product classification code Z12011399.

Similar Classification Devices (Z12011399)

Other Devices by Stryker Instruments

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