GUDIDData
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eudamed_udi Primary ID: 00814247020260

Koala Reusable Cable (Avalon) (UDI 00814247020260)

Manufactured by Clinical Innovations, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Koala Reusable Cable (Avalon) - Primary ID 00814247020260

Device Regulatory Overview

The Koala Reusable Cable (Avalon) (Model/Catalog Number: IPC-5080) is a medical device manufactured by Clinical Innovations, LLC. This product is indexed under FDA Product Code / Category Classification V9011 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-1945-2026 View Full Alert →

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ID: Z-0541-2021 View Full Alert →

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025...

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ID: Z-0123-2016 View Full Alert →

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartu...

🔒 Compromised Lot & Serial Numbers Locked
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Technical Specifications

Model Number
IPC-5080
Product Code / EMDN
V9011
Device Name
Koala Reusable Cable (Phillips)
Database Sync Date
2026-08-09 17:20:50

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 Koala Reusable Cable (Avalon)?

The registered manufacturer of record for Koala Reusable Cable (Avalon) is Clinical Innovations, LLC.

What is the Primary UDI-DI identifier for Koala Reusable Cable (Avalon)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00814247020260.

What classification code is assigned to this device?

This device is registered under product classification code V9011.

Similar Classification Devices (V9011)

Other Devices by Clinical Innovations, LLC

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