GUDIDData
gudid Primary ID: M004R4500TH0

IntellaNav XP (UDI M004R4500TH0)

Manufactured by BOSTON SCIENTIFIC CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IntellaNav XP - Primary ID M004R4500TH0

Device Regulatory Overview

The IntellaNav XP (Model/Catalog Number: M004R4500TH0) is a medical device manufactured by BOSTON SCIENTIFIC CORPORATION. This product is indexed under FDA Product Code / Category Classification OAD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
M004R4500TH0
Product Code / EMDN
OAD
Device Name
Temperature Ablation Catheter
Database Sync Date
2026-08-09 09:26:54

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of IntellaNav XP?

The registered manufacturer of record for IntellaNav XP is BOSTON SCIENTIFIC CORPORATION.

What is the Primary UDI-DI identifier for IntellaNav XP?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is M004R4500TH0.

What classification code is assigned to this device?

This device is registered under product classification code OAD.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint