gudid Primary ID: W16F

Galaxy (UDI W16F)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Galaxy (Model/Catalog Number: W16F) is a medical device manufactured by Ortho Organizers, Inc.. This product is indexed under FDA Product Code / Category Classification EHL within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 2 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2477-2020 View Full Alert →

Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484...

🔒 Compromised Lot & Serial Numbers Locked

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ID: Z-2478-2020 View Full Alert →

Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ...

🔒 Compromised Lot & Serial Numbers Locked

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Technical Specifications

Model Number: W16F
Product Code / EMDN: EHL
Device Name: GALAXY High Shine Enamel Polisher 3/bag Friction Grip
Database Sync Date: 2026-08-09 09:00:45

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 Galaxy?

The registered manufacturer of record for Galaxy is Ortho Organizers, Inc..

What is the Primary UDI-DI identifier for Galaxy?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is W16F.

What classification code is assigned to this device?

This device is registered under product classification code EHL.

Similar Classification Devices (EHL)

Other Devices by Ortho Organizers, Inc.

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