GUDIDData
gudid Primary ID: NA

Impression Taking Refill Kit International (UDI NA)

Manufactured by Westone Laboratories, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Impression Taking Refill Kit International - Primary ID NA

Device Regulatory Overview

The Impression Taking Refill Kit International (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
Impression Taking Refill Kit International
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 Impression Taking Refill Kit International?

The registered manufacturer of record for Impression Taking Refill Kit International is Westone Laboratories, Inc..

What is the Primary UDI-DI identifier for Impression Taking Refill Kit International?

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.

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