BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEADER, pen needles

    DI: 00096295138740 · Model: 31G x 5 mm · HTL STREFA S A
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    LEADER, pen needles
    Primary DI
    00096295138740
    Version / Model
    31G x 5 mm
    Catalog Number
    8468
    Company Name
    HTL STREFA S A
    Labeler DUNS
    422528088
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2019-12-19
    Public Version
    3
    Public Version Date
    2021-08-16
    Public Version Status
    Update
    Public Device Record Key
    fdb7a025-1da9-4c58-b2c8-4ce51d440f8c

    Device Description

    Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMI Needle, Hypodermic, Single Lumen

    GMDN Terms

    Code Name
    44127 Autoinjector needle

    Identifiers

    Type ID
    Package 50096295138745
    Primary 00096295138740
    Unit of Use 10096295138747