BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sterilance SteriHeel Plus Heel Incision Safety Lancet

    DI: 16945630115018 · Model: 30-101428 · Sterilance Medical (Suzhou) Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Sterilance SteriHeel Plus Heel Incision Safety Lancet
    Primary DI
    16945630115018
    Version / Model
    30-101428
    Company Name
    Sterilance Medical (Suzhou) Inc.
    Labeler DUNS
    554434897
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2022-11-30
    Public Version
    1
    Public Version Date
    2022-12-08
    Public Version Status
    New
    Public Device Record Key
    188bc02d-a198-4bdf-b0ac-e5311e1e12aa

    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
    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 36945630115012
    Primary 16945630115018
    Unit of Use 06945630115011