BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sterilance Press Pressure Activated Safety Lancet

    DI: 16945630111973 · Model: 05-052618 · Sterilance Medical (Suzhou) Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Sterilance Press Pressure Activated Safety Lancet
    Primary DI
    16945630111973
    Version / Model
    05-052618
    Company Name
    Sterilance Medical (Suzhou) Inc.
    Labeler DUNS
    554434897
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2022-03-10
    Public Version
    2
    Public Version Date
    2022-07-25
    Public Version Status
    Update
    Public Device Record Key
    ae9d75b4-aabe-42da-a194-ad7599768482

    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
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    GMDN Terms

    Code Name
    61578 Manual blood lancing device, single-use

    Identifiers

    Type ID
    Package 36945630111977
    Primary 16945630111973
    Unit of Use 06945630111976