GUDIDData
gudid Primary ID: 45-4001-02

AZUR Detachment Controller (UDI 45-4001-02)

Manufactured by Microvention, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AZUR Detachment Controller - Primary ID 45-4001-02

Device Regulatory Overview

The AZUR Detachment Controller (Model/Catalog Number: 45-4001-02) is a medical device manufactured by Microvention, Inc.. This product is indexed under FDA Product Code / Category Classification KRD 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
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Unlock Lot Data ($49)

Technical Specifications

Model Number
45-4001-02
Product Code / EMDN
KRD
Device Name
AZUR Detachment Controller
Database Sync Date
2026-08-09 09:12:10

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 AZUR Detachment Controller?

The registered manufacturer of record for AZUR Detachment Controller is Microvention, Inc..

What is the Primary UDI-DI identifier for AZUR Detachment Controller?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 45-4001-02.

What classification code is assigned to this device?

This device is registered under product classification code KRD.

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