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eudamed_udi Primary ID: 00814247020802

traxi Panniculus Retractor Eval Kit (UDI 00814247020802)

Manufactured by Clinical Innovations, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for traxi Panniculus Retractor Eval Kit - Primary ID 00814247020802

Device Regulatory Overview

The traxi Panniculus Retractor Eval Kit (Model/Catalog Number: PRS-EVAL) is a medical device manufactured by Clinical Innovations, LLC. This product is indexed under FDA Product Code / Category Classification Z12080399 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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🔒 Compromised Lot & Serial Numbers Locked
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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...

🔒 Compromised Lot & Serial Numbers Locked
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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
PRS-EVAL
Product Code / EMDN
Z12080399
Device Name
traxi Panniculus Retractor
Database Sync Date
2026-08-09 17:41:49

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 traxi Panniculus Retractor Eval Kit?

The registered manufacturer of record for traxi Panniculus Retractor Eval Kit is Clinical Innovations, LLC.

What is the Primary UDI-DI identifier for traxi Panniculus Retractor Eval Kit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00814247020802.

What classification code is assigned to this device?

This device is registered under product classification code Z12080399.

Similar Classification Devices (Z12080399)

Other Devices by Clinical Innovations, LLC

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