gudid Primary ID: 412-525

GRACE PISTON (UDI 412-525)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The GRACE PISTON (Model/Catalog Number: 412-525) is a medical device manufactured by Grace Medical, Inc.. This product is indexed under FDA Product Code / Category Classification ETB 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-2308-2026 View Full Alert →

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis...

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Technical Specifications

Model Number: 412-525
Product Code / EMDN: ETB
Device Name: GRACE PISTON 0.4MM DIA X 5.25MM L PLATINUM RIBBON/FLUOROPLASTIC
Database Sync Date: 2026-08-09 09:59:39

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 GRACE PISTON?

The registered manufacturer of record for GRACE PISTON is Grace Medical, Inc..

What is the Primary UDI-DI identifier for GRACE PISTON?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 412-525.

What classification code is assigned to this device?

This device is registered under product classification code ETB.

Similar Classification Devices (ETB)

Other Devices by Grace Medical, Inc.

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