gudid Primary ID: NA

SiliClone FIRM 8pk - 32 tips (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 SiliClone FIRM 8pk - 32 tips (Model/Catalog Number: NA) is a medical device manufactured by Westone Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification 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: N/A
Device Name: SiliClone FIRM 8pk - 32 tips
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 SiliClone FIRM 8pk - 32 tips?

The registered manufacturer of record for SiliClone FIRM 8pk - 32 tips is Westone Laboratories, Inc..

What is the Primary UDI-DI identifier for SiliClone FIRM 8pk - 32 tips?

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 .

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