eudamed_udi Primary ID: 00841132136638

ORTHOPEDIATRICS® INSTRUMENTATION (UDI 00841132136638)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ORTHOPEDIATRICS® INSTRUMENTATION (Model/Catalog Number: 01-1300-1040) is a medical device manufactured by OrthoPediatrics Corp.. This product is indexed under FDA Product Code / Category Classification Z12139099 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 01-1300-1040
Product Code / EMDN: Z12139099
Device Name: ORTHOPEDIATRICS® INSTRUMENTATION
Database Sync Date: 2026-08-09 16:30:22

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 ORTHOPEDIATRICS® INSTRUMENTATION?

The registered manufacturer of record for ORTHOPEDIATRICS® INSTRUMENTATION is OrthoPediatrics Corp..

What is the Primary UDI-DI identifier for ORTHOPEDIATRICS® INSTRUMENTATION?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00841132136638.

What classification code is assigned to this device?

This device is registered under product classification code Z12139099.

Similar Classification Devices (Z12139099)

Other Devices by OrthoPediatrics Corp.

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