GUDIDData
gudid Primary ID: 30.12.0053

TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN (UDI 30.12.0053)

Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN - Primary ID 30.12.0053

Device Regulatory Overview

The TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN (Model/Catalog Number: 30.12.0053) is a medical device manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA. This product is indexed under FDA Product Code / Category Classification KMY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
30.12.0053
Product Code / EMDN
KMY
Device Name
TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN
Database Sync Date
2026-08-09 09:05:13

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 TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN?

The registered manufacturer of record for TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN is ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA.

What is the Primary UDI-DI identifier for TERMOPLASTIC PLAQUE FOR ALIGNERS PRO ALIGNER X 125x125x0.76MM - 25UN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 30.12.0053.

What classification code is assigned to this device?

This device is registered under product classification code KMY.

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