GUDIDData
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classification Primary ID: OAD

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (UDI OAD)

Manufactured by

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter - Primary ID OAD

Device Regulatory Overview

The Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (Model/Catalog Number: Unspecified) is a medical device manufactured by . This product is indexed under FDA Product Code / Category Classification OAD within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2755-2026 View Full Alert →

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2793-2026 View Full Alert →

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Product Code / EMDN
OAD
Device Name
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Database Sync Date
2026-08-09 09:00:27

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 Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter?

The registered manufacturer of record for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter is .

What is the Primary UDI-DI identifier for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter?

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

What classification code is assigned to this device?

This device is registered under product classification code OAD.

Similar Classification Devices (OAD)

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