ORJ (UDI W121-16L)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ORJ (Model/Catalog Number: W121-16L) is a medical device manufactured by Fortune Worldwide LLC. This product is indexed under FDA Product Code / Category Classification ECN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: W121-16L
Product Code / EMDN: ECN
Device Name: Orthodontic Niti Archwires for Teeth Correction
Database Sync Date: 2026-08-09 09:01:55

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

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 W121-16L.

What classification code is assigned to this device?

This device is registered under product classification code ECN.

Similar Classification Devices (ECN)

Other Devices by Fortune Worldwide LLC

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint