BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tronex International, Inc.

    DI: 10097604451250 · Model: SMS45125Y · TRONEX INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    100

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    Basic Information

    Brand Name
    Tronex International, Inc.
    Primary DI
    10097604451250
    Version / Model
    SMS45125Y
    Company Name
    TRONEX INTERNATIONAL, INC.
    Labeler DUNS
    615425519
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2022-10-28
    Public Version
    2
    Public Version Date
    2025-08-14
    Public Version Status
    Update
    Public Device Record Key
    99583bf0-87c7-44ae-b60d-a984da7f2603

    Device Description

    Gown, Isolation, Multilayer, Over-the-Head Thumb-Hook, Fluid Resistant, Latex-Free, Yellow, Unisize

    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
    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
    OEA Non-Surgical Isolation Gown
    FME Gown, Examination

    GMDN Terms

    Code Name
    35492 Isolation gown, single-use

    Identifiers

    Type ID
    Unit of Use 00097604451253
    Primary 10097604451250