ORJ (UDI D601-111)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ORJ (Model/Catalog Number: D601-111) is a medical device manufactured by Fortune Worldwide LLC. This product is indexed under FDA Product Code / Category Classification ECM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: D601-111
Product Code / EMDN: ECM
Device Name: Orthodontic Bands, preformed for Teeth Correction
Database Sync Date: 2026-08-09 09:01:55

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 ORJ?

The registered manufacturer of record for ORJ is Fortune Worldwide LLC.

What is the Primary UDI-DI identifier for ORJ?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D601-111.

What classification code is assigned to this device?

This device is registered under product classification code ECM.

Similar Classification Devices (ECM)

Other Devices by Fortune Worldwide LLC

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