eudamed_udi Primary ID: D-ARMF00001720300H00961DZ

OSTEOPLUS (UDI D-ARMF00001720300H00961DZ)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The OSTEOPLUS (Model/Catalog Number: H.0096) is a medical device manufactured by STEELDEC SA. This product is indexed under FDA Product Code / Category Classification Q010399 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: H.0096
Product Code / EMDN: Q010399
Device Name: TOPE Ø3,5 L8
Database Sync Date: 2026-08-09 17:17:25

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 OSTEOPLUS?

The registered manufacturer of record for OSTEOPLUS is STEELDEC SA.

What is the Primary UDI-DI identifier for OSTEOPLUS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-ARMF00001720300H00961DZ.

What classification code is assigned to this device?

This device is registered under product classification code Q010399.

Similar Classification Devices (Q010399)

Other Devices by STEELDEC SA

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