BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tronex International, Inc.

    DI: 10097604882351 · Model: MLN88235Y · TRONEX INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Tronex International, Inc.
    Primary DI
    10097604882351
    Version / Model
    MLN88235Y
    Company Name
    TRONEX INTERNATIONAL, INC.
    Labeler DUNS
    615425519
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2023-08-28
    Public Version
    1
    Public Version Date
    2023-09-05
    Public Version Status
    New
    Public Device Record Key
    74ab25c5-d494-4731-ab14-122ff5865276

    Device Description

    Gown, Isolation, Multilayer, AAMI Level 4, Knitted Cuffs, Neck and Waist Ties, Fluid Impervious, Latex-Free, Yellow, X-Large

    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
    FYC Gown, Isolation, Surgical
    QSO Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs

    GMDN Terms

    Code Name
    35492 Isolation gown, single-use

    Identifiers

    Type ID
    Unit of Use 00097604882354
    Primary 10097604882351

    Customer Contacts

    Phone
    973-335-2888
    Email
    [email protected]