BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GRI

    DI: 16931918100067 · Model: GHN10X50 · GRI Medical & Electronic Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GRI
    Primary DI
    16931918100067
    Version / Model
    GHN10X50
    Company Name
    GRI Medical & Electronic Technology Co., Ltd.
    Labeler DUNS
    679894738
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-29
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    da9aa386-adad-4069-a377-d8a6034e5a48

    Device Description

    Gentleheel Devices are made of lower housing, upper housing, spring, blade, spring holder, blade holder, safety lock, button, etc. Materials of all components and package are medical grade and match the requirement of medical use. The products are EO sterilized.

    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 Lancet, Blood

    GMDN Terms

    Code Name
    61578 Manual blood lancing device, single-use

    Identifiers

    Type ID
    Primary 16931918100067