BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Balloon Applicator

    DI: 04953170062865 · Model: MAJ-864 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Balloon Applicator
    Primary DI
    04953170062865
    Version / Model
    MAJ-864
    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
    79c51cbd-24ee-4c42-9731-bfa54129c0d4
    Distribution End Date
    2022-08-10

    Device Description

    "6842600 OLA MAJ-864 RADIAL SCOPE BALLOON"

    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
    ["Ethylene Oxide", "High-level Disinfectant"]

    Product Codes

    Code Name
    ITX Transducer, ultrasonic, diagnostic
    FDF Colonoscope and accessories, flexible/rigid

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 04953170062865

    Customer Contacts

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