gudid Primary ID: KQ-16104NT

iTool (UDI KQ-16104NT)

Manufactured by Apex (Guangzhou) Tools & Orthopedics Co.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTool (Model/Catalog Number: KQ-16104NT) is a medical device manufactured by Apex (Guangzhou) Tools & Orthopedics Co.. This product is indexed under FDA Product Code / Category Classification HTY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: KQ-16104NT
Product Code / EMDN: HTY
Device Name: K-WIRE D.TROCAR PT. 4 .062 (1.6mm)
Database Sync Date: 2026-08-09 09:05:24

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 iTool?

The registered manufacturer of record for iTool is Apex (Guangzhou) Tools & Orthopedics Co..

What is the Primary UDI-DI identifier for iTool?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KQ-16104NT.

What classification code is assigned to this device?

This device is registered under product classification code HTY.

Similar Classification Devices (HTY)

Other Devices by Apex (Guangzhou) Tools & Orthopedics Co.

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