BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SiliGentle Non-Adhesive Silicone Foam Dressing

    DI: 00616784305714 · Model: 3057 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SiliGentle Non-Adhesive Silicone Foam Dressing
    Primary DI
    00616784305714
    Version / Model
    3057
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-21
    Public Version
    1
    Public Version Date
    2021-06-29
    Public Version Status
    New
    Public Device Record Key
    16028d70-4923-42cc-a349-5f9be0cc5b26

    Device Description

    SiliGentle Non-Adhesive Silicone Foam Dressing, 6"x6", Non-Bordered

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NAD Dressing, Wound, Occlusive

    GMDN Terms

    Code Name
    60470 Pressure-management bandage, silicone

    Identifiers

    Type ID
    Package 00616784305721
    Primary 00616784305714
    Package 00616784305738