BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MITCHELL AORTIC VALVE DILATOR

    DI: B09927002300 · Model: 2700-230 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MITCHELL AORTIC VALVE DILATOR
    Primary DI
    B09927002300
    Version / Model
    2700-230
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-19
    Public Version
    4
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    debebcc8-2675-4759-a61b-298d4731e984
    Distribution End Date
    2018-04-02

    Device Description

    MITCHELL AORTIC VALVE DILATOR SET OF 24

    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
    11268 Vascular dilator, reusable

    Identifiers

    Type ID
    Primary B09927002300

    Customer Contacts

    Phone
    800-821-7496
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K100518 000

    Device Sizes

    Type Value Unit Text
    Length 9 Inch