BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BALLOON APPLICATOR

    DI: 04953170175626 · Model: MAJ-1352 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BALLOON APPLICATOR
    Primary DI
    04953170175626
    Version / Model
    MAJ-1352
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-12
    Public Version
    8
    Public Version Date
    2023-01-16
    Public Version Status
    Update
    Public Device Record Key
    1b0dea2d-324a-4b5e-b175-6d0469bde854
    Distribution End Date
    2022-08-10

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["High-level Disinfectant", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    ITX Transducer, ultrasonic, diagnostic
    ODG Endoscopic ultrasound system, gastroenterology-urology
    EOQ Bronchoscope (flexible or rigid)
    FDS Gastroscope and accessories, flexible/rigid

    GMDN Terms

    Code Name
    62379 Surgical instrument assist arm system, manually-adjusted

    Identifiers

    Type ID
    Primary 04953170175626

    Customer Contacts

    Phone
    +1(800)401-1086
    Email
    [email protected]