GUDIDData
eudamed_udi Primary ID: 04711182609047

Silicone Foley Balloon Catheter (UDI 04711182609047)

Manufactured by FORTUNE MEDICAL INSTRUMENT CORP.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Silicone Foley Balloon Catheter - Primary ID 04711182609047

Device Regulatory Overview

The Silicone Foley Balloon Catheter (Model/Catalog Number: 65 20 18) is a medical device manufactured by FORTUNE MEDICAL INSTRUMENT CORP.. This product is indexed under FDA Product Code / Category Classification A060102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
65 20 18
Product Code / EMDN
A060102
Device Name
Silicone Foley Balloon Catheter
Database Sync Date
2026-08-09 16:29:34

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 Silicone Foley Balloon Catheter?

The registered manufacturer of record for Silicone Foley Balloon Catheter is FORTUNE MEDICAL INSTRUMENT CORP..

What is the Primary UDI-DI identifier for Silicone Foley Balloon Catheter?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04711182609047.

What classification code is assigned to this device?

This device is registered under product classification code A060102.

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