BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PROOF

    DI: D8328004C31 · Model: 8004C-3 · PLASDENT CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    PROOF
    Primary DI
    D8328004C31
    Version / Model
    8004C-3
    Catalog Number
    8004C-3
    Company Name
    PLASDENT CORPORATION
    Labeler DUNS
    190377184
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-03-25
    Public Version
    1
    Public Version Date
    2022-04-04
    Public Version Status
    New
    Public Device Record Key
    c5b1f7a8-cdb4-4644-9d79-f8f918beea99

    Device Description

    Premium Barrier Gown, Yellow

    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
    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

    GMDN Terms

    Code Name
    35091 Surgical gown, single-use

    Identifiers

    Type ID
    Unit of Use D8328004C30
    Primary D8328004C31