eudamed_udi Primary ID: +D102SGKAX0

Unspecified Brand (UDI +D102SGKAX0)

Manufactured by Implant solutions Pty Ltd (T/A Osteon Medical)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: SGKAX) is a medical device manufactured by Implant solutions Pty Ltd (T/A Osteon Medical). This product is indexed under FDA Product Code / Category Classification Q010280 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SGKAX
Product Code / EMDN: Q010280
Device Name: Scan Gauge Kit
Database Sync Date: 2026-08-09 16:29:13

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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Implant solutions Pty Ltd (T/A Osteon Medical).

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +D102SGKAX0.

What classification code is assigned to this device?

This device is registered under product classification code Q010280.

Similar Classification Devices (Q010280)

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