gudid Primary ID: 212269

DOA Kit, 5D Plus (UDI 212269)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The DOA Kit, 5D Plus (Model/Catalog Number: 212269) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NTK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 212269
Product Code / EMDN: NTK
Device Name: DOA Kits
Database Sync Date: 2026-08-09 09:40:14

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 DOA Kit, 5D Plus?

The registered manufacturer of record for DOA Kit, 5D Plus is Align Technology, Inc..

What is the Primary UDI-DI identifier for DOA Kit, 5D Plus?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 212269.

What classification code is assigned to this device?

This device is registered under product classification code NTK.

Similar Classification Devices (NTK)

Other Devices by Align Technology, Inc.

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