BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04035873068495 · Model: 8300053499 · Henke-Sass, Wolf GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    04035873068495
    Version / Model
    8300053499
    Catalog Number
    8300053499
    Company Name
    Henke-Sass, Wolf GmbH
    Labeler DUNS
    317326411
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-17
    Public Version
    1
    Public Version Date
    2021-02-25
    Public Version Status
    New
    Public Device Record Key
    60d5647e-479b-4134-990b-20c458a64ac8

    Device Description

    25 FR. CYSTOSCOPE SHEATH

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    37086 Endoscope sheath, reusable

    Identifiers

    Type ID
    Primary 04035873068495