GUDIDData
gudid Primary ID: KITCEMENT-US

CEMENT KIT (UDI KITCEMENT-US)

Manufactured by TECRES SPA

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CEMENT KIT - Primary ID KITCEMENT-US

Device Regulatory Overview

The CEMENT KIT (Model/Catalog Number: KITCEMENT-US) 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
KITCEMENT-US
Product Code / EMDN
LOD
Device Name
Mendec Spine HV is a highly viscous, radio-opaque acrylic resin (PMMA based) for vertebral augmentation procedures available as a closed mixing unit (the powder and liquid components are enclosed in a syringe-like device).
Database Sync Date
2026-08-09 09:05:06

Full Regulatory Attributes

🔒 Token Gated
{
    "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 CEMENT KIT?

The registered manufacturer of record for CEMENT KIT is TECRES SPA.

What is the Primary UDI-DI identifier for CEMENT KIT?

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

What classification code is assigned to this device?

This device is registered under product classification code LOD.

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