BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TUBBS MITRAL VALVE DILATOR

    DI: 00192896010727 · Model: 2700-120 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TUBBS MITRAL VALVE DILATOR
    Primary DI
    00192896010727
    Version / Model
    2700-120
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-24
    Public Version
    1
    Public Version Date
    2018-09-24
    Public Version Status
    New
    Public Device Record Key
    1299e946-2a52-4584-b66a-e3b110be8c8d

    Device Description

    TUBBS MITRAL VALVE DILATOR

    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
    ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    DWP Dilator, Vessel, Surgical

    GMDN Terms

    Code Name
    11255 Mitral valve dilator

    Identifiers

    Type ID
    Previous B09927001200
    Primary 00192896010727

    Customer Contacts

    Phone
    303-790-9411
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K100518 000

    Device Sizes

    Type Value Unit Text
    Outer Diameter 8 Millimeter