GUDIDData
eudamed_udi Primary ID: 04260484571229

OW100S (UDI 04260484571229)

Manufactured by MTS Medical AG (Aktiengesellschaft)

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OW100S - Primary ID 04260484571229

Device Regulatory Overview

The OW100S (Model/Catalog Number: 1000019) is a medical device manufactured by MTS Medical AG (Aktiengesellschaft). This product is indexed under FDA Product Code / Category Classification Z12139001 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1000019
Product Code / EMDN
Z12139001
Device Name
OW100/OW100S
Database Sync Date
2026-08-09 17:09:45

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 OW100S?

The registered manufacturer of record for OW100S is MTS Medical AG (Aktiengesellschaft).

What is the Primary UDI-DI identifier for OW100S?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04260484571229.

What classification code is assigned to this device?

This device is registered under product classification code Z12139001.

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