GUDIDData
gudid Primary ID: FREDX5532-PMA

Stent (UDI FREDX5532-PMA)

Manufactured by Microvention, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Stent - Primary ID FREDX5532-PMA

Device Regulatory Overview

The Stent (Model/Catalog Number: FREDX5532-PMA) is a medical device manufactured by Microvention, Inc.. This product is indexed under FDA Product Code / Category Classification OUT 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-1220-2020 View Full Alert →

Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-48...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1222-2020 View Full Alert →

Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040,...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1223-2020 View Full Alert →

Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-4...

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

Technical Specifications

Model Number
FREDX5532-PMA
Product Code / EMDN
OUT
Device Name
FRED-X 27
Database Sync Date
2026-08-09 09:13:58

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 Stent?

The registered manufacturer of record for Stent is Microvention, Inc..

What is the Primary UDI-DI identifier for Stent?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FREDX5532-PMA.

What classification code is assigned to this device?

This device is registered under product classification code OUT.

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