GUDIDData
gudid Primary ID: 650-075

OFFSET ALTO CONCISE PARTIAL (UDI 650-075)

Manufactured by Grace Medical, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for OFFSET ALTO CONCISE PARTIAL - Primary ID 650-075

Device Regulatory Overview

The OFFSET ALTO CONCISE PARTIAL (Model/Catalog Number: 650-075) 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
650-075
Product Code / EMDN
ETB
Device Name
OFFSET ALTO CONCISE PARTIAL SIZERS INCLUDED TITANIUM/SILICONE
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 OFFSET ALTO CONCISE PARTIAL?

The registered manufacturer of record for OFFSET ALTO CONCISE PARTIAL is Grace Medical, Inc..

What is the Primary UDI-DI identifier for OFFSET ALTO CONCISE PARTIAL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 650-075.

What classification code is assigned to this device?

This device is registered under product classification code ETB.

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