BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TransForm McCarthy Annuloplasty Ring

    DI: B040TF380 · Model: TF-38 · GENESEE BIOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TransForm McCarthy Annuloplasty Ring
    Primary DI
    B040TF380
    Version / Model
    TF-38
    Company Name
    GENESEE BIOMEDICAL, INC.
    Labeler DUNS
    939872651
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-12-23
    Public Version
    1
    Public Version Date
    2024-12-31
    Public Version Status
    New
    Public Device Record Key
    6cf821f7-387d-4ea5-9ec5-ac42ee9c23f8

    Device Description

    Annuloplasty Ring

    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
    Yes
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KRH Ring, Annuloplasty

    GMDN Terms

    Code Name
    66338 Mitral/tricuspid annuloplasty ring, open-surgery

    Identifiers

    Type ID
    Package B040TF38
    Primary B040TF380

    Customer Contacts

    Phone
    800 786-4890
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K232599 000