gudid Primary ID: 14000ES16A

ESHEATH OPTIMA (UDI 14000ES16A)

Manufactured by Edwards Lifesciences LLC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The ESHEATH OPTIMA (Model/Catalog Number: 14000ES16A) is a medical device manufactured by Edwards Lifesciences LLC. This product is indexed under FDA Product Code / Category Classification DYB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 14000ES16A
Product Code / EMDN: DYB
Device Name: eSheath Optima Introducer Set (16F)
Database Sync Date: 2026-08-09 09:04:21

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 ESHEATH OPTIMA?

The registered manufacturer of record for ESHEATH OPTIMA is Edwards Lifesciences LLC.

What is the Primary UDI-DI identifier for ESHEATH OPTIMA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 14000ES16A.

What classification code is assigned to this device?

This device is registered under product classification code DYB.

Similar Classification Devices (DYB)

Other Devices by Edwards Lifesciences LLC

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