GUDIDData
gudid Primary ID: 4045-422

Masel (UDI 4045-422)

Manufactured by Ortho Organizers, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Masel - Primary ID 4045-422

Device Regulatory Overview

The Masel (Model/Catalog Number: 4045-422) is a medical device manufactured by Ortho Organizers, Inc.. This product is indexed under FDA Product Code / Category Classification ECN 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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Unlock Lot Data ($49)

Technical Specifications

Model Number
4045-422
Product Code / EMDN
ECN
Device Name
CLOSED RECTANGULAR CAST BALL HOOK AND STOP 021x025
Database Sync Date
2026-08-09 09:01:42

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Masel?

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

What is the Primary UDI-DI identifier for Masel?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4045-422.

What classification code is assigned to this device?

This device is registered under product classification code ECN.

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