BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biopsy valve

    DI: 04953170063947 · Model: MB-358 · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Biopsy valve
    Primary DI
    04953170063947
    Version / Model
    MB-358
    Catalog Number
    GX0283
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    9
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    8e275f05-c817-4a50-b8b8-8f6ff1359e2a

    Device Description

    "MB-358 SEMI-DISPOSABLE BIOPSY VALVE"

    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
    ["High-level Disinfectant", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    FDS Gastroscope And Accessories, Flexible/Rigid
    FDF Colonoscope And Accessories, Flexible/Rigid
    NWB Endoscope, Accessories, Narrow Band Spectrum

    GMDN Terms

    Code Name
    64366 Endoscopic biopsy valve, reusable

    Identifiers

    Type ID
    Primary 04953170063947
    Unit of Use 84953170063943

    Customer Contacts

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