BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tronex International, Inc.

    DI: 10097604966204 · Model: 9662-05 · TRONEX INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    500

    Basic Information

    Brand Name
    Tronex International, Inc.
    Primary DI
    10097604966204
    Version / Model
    9662-05
    Company Name
    TRONEX INTERNATIONAL, INC.
    Labeler DUNS
    615425519
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    500
    Record Status
    Published
    Publish Date
    2022-10-28
    Public Version
    2
    Public Version Date
    2023-08-22
    Public Version Status
    Update
    Public Device Record Key
    83fb6856-d968-4b66-aaa5-2529b835cd82

    Device Description

    Glove, Exam, Nitrile, Extra-Thick, Chemotherapy Rated, Fully Textured, 12", Powder-Free, Latex-Free, Blue, Extra-Small

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

    GMDN Terms

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

    Identifiers

    Type ID
    Unit of Use 00097604966207
    Primary 10097604966204