BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Medical Face Shield

    DI: 00810050851985 · Model: FS0101 · TYPENEX MEDICAL LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    200

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    Basic Information

    Brand Name
    Medical Face Shield
    Primary DI
    00810050851985
    Version / Model
    FS0101
    Company Name
    TYPENEX MEDICAL LLC
    Labeler DUNS
    600850213
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    200
    Record Status
    Published
    Publish Date
    2022-11-28
    Public Version
    2
    Public Version Date
    2025-01-10
    Public Version Status
    Update
    Public Device Record Key
    fa0c72b3-7d55-4080-b1a3-ddbb5c60fe67
    Distribution End Date
    2024-12-31

    Device Description

    Medical Face Shield

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    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
    LYU Accessory, Surgical Apparel

    GMDN Terms

    Code Name
    11961 Face splash shield, single-use

    Identifiers

    Type ID
    Primary 00810050851985
    Unit of Use 00810050851978