BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Unistik TinyTouch

    DI: 00384701200014 · Model: AT 1200 · OWEN MUMFORD USA INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Unistik TinyTouch
    Primary DI
    00384701200014
    Version / Model
    AT 1200
    Company Name
    OWEN MUMFORD USA INCORPORATED
    Labeler DUNS
    803401454
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2023-03-22
    Public Version
    1
    Public Version Date
    2023-03-30
    Public Version Status
    New
    Public Device Record Key
    d3a6335b-6c28-46d9-9f8f-e96e4440f165

    Device Description

    Unistik TinyTouch Preemie .85mm x 1.75mm

    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
    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
    No
    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 00384701200021
    Primary 00384701200014
    Package 00384701200038
    Unit of Use 00384701200007