BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    MITCHELL AORTIC VALVE DILATOR

    DI: B09927002200 · Model: 2700-220 · 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
    B09927002200
    Version / Model
    2700-220
    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
    95f63c82-c34c-4186-a77d-892ff30fc1ad
    Distribution End Date
    2018-04-02

    Device Description

    MITCHELL AORTIC 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
    11268 Vascular dilator, reusable

    Identifiers

    Type ID
    Primary B09927002200

    Premarket Submissions

    Submission Number Supplement Number
    K100518 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 20mm 9"