BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Lucky Super Soft

    DI: 00808829102536 · Model: Kit · DELTA BRANDS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Lucky Super Soft
    Primary DI
    00808829102536
    Version / Model
    Kit
    Company Name
    DELTA BRANDS INC.
    Labeler DUNS
    102672008
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-13
    Public Version
    1
    Public Version Date
    2022-12-21
    Public Version Status
    New
    Public Device Record Key
    5b590c53-f846-4321-b354-f8b7586ea1bd

    Device Description

    First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    OHO First Aid Kit Without Drug

    GMDN Terms

    Code Name
    44047 First aid kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00808829102536