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    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEPRO.US Nitrile Standard Class Series 400

    DI: 00850578007860 · Model: BX - 400 Nitrile Small · HEPRO.US INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    HEPRO.US Nitrile Standard Class Series 400
    Primary DI
    00850578007860
    Version / Model
    BX - 400 Nitrile Small
    Company Name
    HEPRO.US INC.
    Labeler DUNS
    080061451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2017-06-21
    Public Version
    3
    Public Version Date
    2020-06-19
    Public Version Status
    Update
    Public Device Record Key
    38e88c44-0274-4dd8-a113-b07572244d99

    Device Description

    Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Small 1 Box 100pcs HEPRO.US Nitrile Standard Class Series 400

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZA Polymer Patient Examination Glove

    GMDN Terms

    Code Name
    56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

    Identifiers

    Type ID
    Primary 00850578007860
    Unit of Use 85057800786001