GUDIDData
gudid Primary ID: 1

CLEARTEK (UDI 1)

Manufactured by Ortho Solutions, LC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CLEARTEK - Primary ID 1

Device Regulatory Overview

The CLEARTEK (Model/Catalog Number: 1) is a medical device manufactured by Ortho Solutions, LC. This product is indexed under FDA Product Code / Category Classification NJM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1
Product Code / EMDN
NJM
Device Name
Clear Orthodontic Brackets
Database Sync Date
2026-08-09 09:03:36

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 CLEARTEK?

The registered manufacturer of record for CLEARTEK is Ortho Solutions, LC.

What is the Primary UDI-DI identifier for CLEARTEK?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.

What classification code is assigned to this device?

This device is registered under product classification code NJM.

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