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    FDA UDI In Commercial Distribution 🇺🇸 United States

    HEPRO.US Sterile Latex Surgical Gloves Size X-Large 8.5"

    DI: 00854427007209 · Model: BX - Surgical Latex Gloves 8.5" · HEPRO.US INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    HEPRO.US Sterile Latex Surgical Gloves Size X-Large 8.5"
    Primary DI
    00854427007209
    Version / Model
    BX - Surgical Latex Gloves 8.5"
    Company Name
    HEPRO.US INC.
    Labeler DUNS
    080061451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    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
    828538da-d46e-485a-ac1b-6c17d371f785

    Device Description

    Surgical Gloves-Non-powder Sterilized by Gamma Radiation, Sterile Until 50 pairs 1- Box

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGO Surgeon'S Gloves

    GMDN Terms

    Code Name
    47178 Hevea-latex surgical glove, non-powdered, non-antimicrobial

    Identifiers

    Type ID
    Primary 00854427007209
    Unit of Use 85442700720901