gudid Primary ID: MAJ-249

BALLOON3 (UDI MAJ-249)

Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BALLOON3 (Model/Catalog Number: MAJ-249) is a medical device manufactured by OLYMPUS MEDICAL SYSTEMS CORP.. This product is indexed under FDA Product Code / Category Classification ODG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MAJ-249
Product Code / EMDN: ODG
Device Name
Database Sync Date: 2026-08-09 09:46:01

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 BALLOON3?

The registered manufacturer of record for BALLOON3 is OLYMPUS MEDICAL SYSTEMS CORP..

What is the Primary UDI-DI identifier for BALLOON3?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MAJ-249.

What classification code is assigned to this device?

This device is registered under product classification code ODG.

Similar Classification Devices (ODG)

Other Devices by OLYMPUS MEDICAL SYSTEMS CORP.

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