gudid Primary ID: COLLECTION SET CARDIO BX-120 m

XTRA (UDI COLLECTION SET CARDIO BX-120 m)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The XTRA (Model/Catalog Number: COLLECTION SET CARDIO BX-120 m) is a medical device manufactured by SORIN GROUP ITALIA SRL. This product is indexed under FDA Product Code / Category Classification DTN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: COLLECTION SET CARDIO BX-120 m
Product Code / EMDN: DTN
Device Name
Database Sync Date: 2026-08-09 09:05:05

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 XTRA?

The registered manufacturer of record for XTRA is SORIN GROUP ITALIA SRL.

What is the Primary UDI-DI identifier for XTRA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is COLLECTION SET CARDIO BX-120 m.

What classification code is assigned to this device?

This device is registered under product classification code DTN.

Similar Classification Devices (DTN)

Other Devices by SORIN GROUP ITALIA SRL

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