gudid Primary ID: 16-0002

Surgi-Max Drill System (UDI 16-0002)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Surgi-Max Drill System (Model/Catalog Number: 16-0002) is a medical device manufactured by ELLIQUENCE, LLC. This product is indexed under FDA Product Code / Category Classification GEY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 16-0002
Product Code / EMDN: GEY
Device Name
Database Sync Date: 2026-08-09 09:21:00

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 Surgi-Max Drill System?

The registered manufacturer of record for Surgi-Max Drill System is ELLIQUENCE, LLC.

What is the Primary UDI-DI identifier for Surgi-Max Drill System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 16-0002.

What classification code is assigned to this device?

This device is registered under product classification code GEY.

Similar Classification Devices (GEY)

Other Devices by ELLIQUENCE, LLC

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