BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 07613327507140 · Model: N/A · STRYKER SUSTAINABILITY SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    07613327507140
    Version / Model
    N/A
    Catalog Number
    50-601XL
    Company Name
    STRYKER SUSTAINABILITY SOLUTIONS, INC.
    Labeler DUNS
    020198912
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-26
    Public Version
    1
    Public Version Date
    2020-11-03
    Public Version Status
    New
    Public Device Record Key
    d2a8311c-e01e-4de9-b691-54726de266d4

    Device Description

    MyoSure XL Tissue Removal Device for Fluent

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIH HYSTEROSCOPE (AND ACCESSORIES)

    GMDN Terms

    Code Name
    62952 Hysteroscopic resection device

    Identifiers

    Type ID
    Package 37613327507141
    Primary 07613327507140
    Package 57613327507145

    Customer Contacts

    Phone
    +1(888)888-3433
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K201756 000