eudamed_udi Primary ID: 08809416061368

Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System (UDI 08809416061368)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System (Model/Catalog Number: ODS-04) is a medical device manufactured by OSTEONIC Co., Ltd.. This product is indexed under FDA Product Code / Category Classification L26 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ODS-04
Product Code / EMDN: L26
Device Name: Surgical Instrument
Database Sync Date: 2026-08-09 16:29:42

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 Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System?

The registered manufacturer of record for Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System is OSTEONIC Co., Ltd..

What is the Primary UDI-DI identifier for Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08809416061368.

What classification code is assigned to this device?

This device is registered under product classification code L26.

Similar Classification Devices (L26)

Other Devices by OSTEONIC Co., Ltd.

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