GUDIDData
eudamed_udi Primary ID: 20607915123905

GelPort Laparoscopic System (UDI 20607915123905)

Manufactured by Applied Medical Resources Corporation

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GelPort Laparoscopic System - Primary ID 20607915123905

Device Regulatory Overview

The GelPort Laparoscopic System (Model/Catalog Number: C8XX2CE) is a medical device manufactured by Applied Medical Resources Corporation. This product is indexed under FDA Product Code / Category Classification K0108 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
C8XX2CE
Product Code / EMDN
K0108
Device Name
GelPortยฎ Hand Access
Database Sync Date
2026-08-09 16:50:45

Full Regulatory Attributes

๐Ÿ”’ 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 GelPort Laparoscopic System?

The registered manufacturer of record for GelPort Laparoscopic System is Applied Medical Resources Corporation.

What is the Primary UDI-DI identifier for GelPort Laparoscopic System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 20607915123905.

What classification code is assigned to this device?

This device is registered under product classification code K0108.

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