BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Balloon Applicator

    DI: 04953170368547 · Model: MAJ-564 · 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
    04953170368547
    Version / Model
    MAJ-564
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    6
    Public Version Date
    2021-11-30
    Public Version Status
    Update
    Public Device Record Key
    a225e400-4328-4a15-b224-ad874cab8671

    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
    Yes
    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
    FED endoscopic access overtube, gastroenterology-urology
    ODG Endoscopic ultrasound system, gastroenterology-urology

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 04953170368547

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K982734 000