BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Premium Plus

    DI: D8381145BLUE4 · Model: 1145-BLUE · Premium Plus International Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Premium Plus
    Primary DI
    D8381145BLUE4
    Version / Model
    1145-BLUE
    Company Name
    Premium Plus International Limited
    Labeler DUNS
    668367758
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-07
    Public Version
    2
    Public Version Date
    2020-04-06
    Public Version Status
    Update
    Public Device Record Key
    531dcd5d-259d-4586-8c10-35ed9976178c

    Device Description

    Face Shields

    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
    Yes
    PM Exempt
    Yes
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

    GMDN Terms

    Code Name
    11961 Face splash shield, single-use

    Identifiers

    Type ID
    Package D8381145BLUE8
    Primary D8381145BLUE4