BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Plasdent Fluid Proof Earloop Mask

    DI: D832MK110 · Model: MK1 · PLASDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Plasdent Fluid Proof Earloop Mask
    Primary DI
    D832MK110
    Version / Model
    MK1
    Catalog Number
    MK1-10L
    Company Name
    PLASDENT CORPORATION
    Labeler DUNS
    190377184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-21
    Public Version
    5
    Public Version Date
    2023-09-13
    Public Version Status
    Update
    Public Device Record Key
    42a42b7a-a7ee-4bd0-a69c-7c0df5d59c64

    Device Description

    FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FXX Mask, Surgical

    GMDN Terms

    Code Name
    57792 Surgical/medical respirator, antimicrobial

    Identifiers

    Type ID
    Package D832MK1101
    Primary D832MK110
    Package D832MK1105
    Package D832MK1102

    Premarket Submissions

    Submission Number Supplement Number
    K133070 000