GUDIDData
gudid Primary ID: PC1025A

Perfusion Clamp with Adaptor (UDI PC1025A)

Manufactured by INSTITUT GEORGES LOPEZ

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Perfusion Clamp with Adaptor - Primary ID PC1025A

Device Regulatory Overview

The Perfusion Clamp with Adaptor (Model/Catalog Number: PC1025A) is a medical device manufactured by INSTITUT GEORGES LOPEZ. This product is indexed under FDA Product Code / Category Classification FKK within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2220-2025 View Full Alert →

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: I...

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Technical Specifications

Model Number
PC1025A
Product Code / EMDN
FKK
Device Name
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
Database Sync Date
2026-08-09 09:48:33

Full Regulatory Attributes

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{
    "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 Perfusion Clamp with Adaptor?

The registered manufacturer of record for Perfusion Clamp with Adaptor is INSTITUT GEORGES LOPEZ.

What is the Primary UDI-DI identifier for Perfusion Clamp with Adaptor?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PC1025A.

What classification code is assigned to this device?

This device is registered under product classification code FKK.

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