BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Xpert

    DI: 00841277109023 · Model: SGXN 103 · Harps USA, Inc.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Xpert
    Primary DI
    00841277109023
    Version / Model
    SGXN 103
    Catalog Number
    SGXN 103
    Company Name
    Harps USA, Inc.
    Labeler DUNS
    004072158
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2025-01-24
    Public Version
    2
    Public Version Date
    2025-10-16
    Public Version Status
    Update
    Public Device Record Key
    5cd9c851-967f-413d-be89-febb9858d520
    Distribution End Date
    2025-01-24

    Device Description

    Nitrile Exam Glove, PF size m

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZC Medical Glove, Specialty
    OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
    QDO Fentanyl And Other Opioid Protection Glove
    LZA Polymer Patient Examination Glove

    GMDN Terms

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

    Identifiers

    Type ID
    Unit of Use 00841277109085
    Primary 00841277109023