GUDIDData
gudid Primary ID: 1147578

Keystone Industries (UDI 1147578)

Manufactured by Keystone Industries

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Keystone Industries - Primary ID 1147578

Device Regulatory Overview

The Keystone Industries (Model/Catalog Number: 1147578) is a medical device manufactured by Keystone Industries. This product is indexed under FDA Product Code / Category Classification EMB within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2580-2023 View Full Alert →

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2579-2023 View Full Alert →

Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to p...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0630-2024 View Full Alert →

KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, reposi...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
1147578
Product Code / EMDN
EMB
Device Name
Zinc Oxide Powder USP 1 lb (453g)
Database Sync Date
2026-08-09 09:41:48

Full Regulatory Attributes

🔒 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 Keystone Industries?

The registered manufacturer of record for Keystone Industries is Keystone Industries.

What is the Primary UDI-DI identifier for Keystone Industries?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1147578.

What classification code is assigned to this device?

This device is registered under product classification code EMB.

Programmatic Export

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