gudid Primary ID: 640

BOJRAB ALTO PRECUT (UDI 640)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BOJRAB ALTO PRECUT (Model/Catalog Number: 640) 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: 640
Product Code / EMDN: ETA
Device Name: BOJRAB ALTO PRECUT TOTAL 5.00 - 6.25MM L SIZERS INCLUDED 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 BOJRAB ALTO PRECUT?

The registered manufacturer of record for BOJRAB ALTO PRECUT is Grace Medical, Inc..

What is the Primary UDI-DI identifier for BOJRAB ALTO PRECUT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 640.

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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