BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DeRoyal

    DI: 00749756054300 · Model: 46-216 · DEROYAL INDUSTRIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DeRoyal
    Primary DI
    00749756054300
    Version / Model
    46-216
    Catalog Number
    46-216
    Company Name
    DEROYAL INDUSTRIES, INC.
    Labeler DUNS
    096372255
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-02
    Public Version
    1
    Public Version Date
    2023-02-10
    Public Version Status
    New
    Public Device Record Key
    975ad3c1-de21-41b0-9eb0-dbb9e0d60c13

    Device Description

    Episeal Wound Closure Strip

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KGX Tape and bandage, adhesive

    GMDN Terms

    Code Name
    32207 Skin-closure adhesive strip

    Identifiers

    Type ID
    Package 50749756054305
    Package 30749756054301
    Primary 00749756054300