gudid Primary ID: NA

EZ Mold Singles 24 Pk Blue (UDI NA)

Manufactured by Westone Laboratories, Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The EZ Mold Singles 24 Pk Blue (Model/Catalog Number: NA) is a medical device manufactured by Westone Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification LDG 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-2058-2012 View Full Alert →

Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bott...

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Technical Specifications

Model Number: NA
Product Code / EMDN: LDG
Device Name: EZ Mold Singles 24 Pk Blue
Database Sync Date: 2026-08-09 09:37:40

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 EZ Mold Singles 24 Pk Blue?

The registered manufacturer of record for EZ Mold Singles 24 Pk Blue is Westone Laboratories, Inc..

What is the Primary UDI-DI identifier for EZ Mold Singles 24 Pk Blue?

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

What classification code is assigned to this device?

This device is registered under product classification code LDG.

Similar Classification Devices (LDG)

Other Devices by Westone Laboratories, Inc.

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