BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SINUREP

    DI: 08056772679946 · Model: SR20080-02 · MEDAX SRL UNIPERSONALE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SINUREP
    Primary DI
    08056772679946
    Version / Model
    SR20080-02
    Company Name
    MEDAX SRL UNIPERSONALE
    Labeler DUNS
    440211428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-26
    Public Version
    1
    Public Version Date
    2018-06-26
    Public Version Status
    New
    Public Device Record Key
    7086f0ce-d33c-4740-8cc4-43e2175f69b1

    Device Description

    Breast localization needle Mod. SINUREP 20G x 80 mm

    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 Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    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
    MIJ Needle, Tumor Localization

    GMDN Terms

    Code Name
    47020 Imaging lesion localization marker, external, single-use

    Identifiers

    Type ID
    Package 18056772679943
    Primary 08056772679946