BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    The OZAKI AVPro Sizer Set

    DI: 04570057303967 · Model: TC-OZA-USB1XN · TOKYO SENTAN GEKA CHIRYO KENKYU CENTER, K.K.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    The OZAKI AVPro Sizer Set
    Primary DI
    04570057303967
    Version / Model
    TC-OZA-USB1XN
    Company Name
    TOKYO SENTAN GEKA CHIRYO KENKYU CENTER, K.K.
    Labeler DUNS
    718261532
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-17
    Public Version
    1
    Public Version Date
    2026-01-26
    Public Version Status
    New
    Public Device Record Key
    b3a973fa-b809-45c6-a8c6-94f87bb085c7

    Device Description

    Basic Sizer set for Adult and Normal aortic annulus

    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
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide, Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DTI Sizer, Heart-Valve, Prosthesis

    GMDN Terms

    Code Name
    61604 Heart valve annulus sizer, single-use

    Identifiers

    Type ID
    Primary 04570057303967

    Customer Contacts

    Phone
    1-800-334-5464
    Email
    [email protected]