BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Annular Sizer Aortic

    DI: B040ASR19210 · Model: ASR19/21 · GENESEE BIOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Annular Sizer Aortic
    Primary DI
    B040ASR19210
    Version / Model
    ASR19/21
    Company Name
    GENESEE BIOMEDICAL, INC.
    Labeler DUNS
    939872651
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-05
    Public Version
    1
    Public Version Date
    2024-12-13
    Public Version Status
    New
    Public Device Record Key
    f73e47f2-61f9-444d-9842-c91640439a8f

    Device Description

    Aortic Repair Tool Kit - Annular Sizers

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DWS Instruments, Surgical, Cardiovascular

    GMDN Terms

    Code Name
    47684 Heart valve annulus sizer, reusable

    Identifiers

    Type ID
    Primary B040ASR19210
    Package B040ASR1921