gudid Primary ID: 630-M1

HA LITE ALTO (UDI 630-M1)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The HA LITE ALTO (Model/Catalog Number: 630-M1) is a medical device manufactured by Grace Medical, Inc.. This product is indexed under FDA Product Code / Category Classification ETA 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: 630-M1
Product Code / EMDN: ETA
Device Name: HA LITE ALTO TOTAL 15MM LENGTH HA/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 HA LITE ALTO?

The registered manufacturer of record for HA LITE ALTO is Grace Medical, Inc..

What is the Primary UDI-DI identifier for HA LITE ALTO?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 630-M1.

What classification code is assigned to this device?

This device is registered under product classification code ETA.

Similar Classification Devices (ETA)

Other Devices by Grace Medical, Inc.

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