gudid Primary ID: 65.01.113US

MectaCem-X LV with Gentamicin (UDI 65.01.113US)

Manufactured by TECRES SPA

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

Scannable UDI-DI Representation

Device Regulatory Overview

The MectaCem-X LV with Gentamicin (Model/Catalog Number: 65.01.113US) is a medical device manufactured by TECRES SPA. This product is indexed under FDA Product Code / Category Classification LOD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 65.01.113US
Product Code / EMDN: LOD
Device Name: MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Database Sync Date: 2026-08-09 09:05:06

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 MectaCem-X LV with Gentamicin?

The registered manufacturer of record for MectaCem-X LV with Gentamicin is TECRES SPA.

What is the Primary UDI-DI identifier for MectaCem-X LV with Gentamicin?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 65.01.113US.

What classification code is assigned to this device?

This device is registered under product classification code LOD.

Similar Classification Devices (LOD)

Other Devices by TECRES SPA

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