BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SURGIPLUS

    DI: 04895237102124 · Model: 1 · KENPAX INTERNATIONAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SURGIPLUS
    Primary DI
    04895237102124
    Version / Model
    1
    Catalog Number
    68-6201-B
    Company Name
    KENPAX INTERNATIONAL LIMITED
    Labeler DUNS
    686206765
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-15
    Public Version
    2
    Public Version Date
    2020-07-28
    Public Version Status
    Update
    Public Device Record Key
    5ad41a22-6df7-497c-be25-524a53e6d877

    Device Description

    PE Film Gown

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OEA Non-Surgical Isolation Gown

    GMDN Terms

    Code Name
    35492 Isolation gown, single-use

    Identifiers

    Type ID
    Primary 04895237102124
    Package 04895237102117