GUDIDData
gudid Primary ID: 692-125

DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS (UDI 692-125)

Manufactured by Grace Medical, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS - Primary ID 692-125

Device Regulatory Overview

The DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS (Model/Catalog Number: 692-125) 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
692-125
Product Code / EMDN
ETB
Device Name
DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.25MM FIXED LENGTH HA/TITANIUM/NITINOL
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 DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS?

The registered manufacturer of record for DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS is Grace Medical, Inc..

What is the Primary UDI-DI identifier for DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 692-125.

What classification code is assigned to this device?

This device is registered under product classification code ETB.

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