BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gen-X®

    DI: 09551005270659 · Model: CPFEMD · SMART GLOVE INTERNATIONAL PTE. LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Gen-X®
    Primary DI
    09551005270659
    Version / Model
    CPFEMD
    Company Name
    SMART GLOVE INTERNATIONAL PTE. LTD.
    Labeler DUNS
    659506974
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2023-10-31
    Public Version
    1
    Public Version Date
    2023-11-08
    Public Version Status
    New
    Public Device Record Key
    c937bb9f-585c-40d7-98a6-5d143b284347

    Device Description

    Polychloroprene C-series Examination Gloves, Powder Free - XS

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZA Polymer Patient Examination Glove

    GMDN Terms

    Code Name
    56288 Polychloroprene examination/treatment glove, non-powdered

    Identifiers

    Type ID
    Package 19551005270656
    Primary 09551005270659
    Unit of Use 29551005270653