BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mack's

    DI: 00033732000109 · Model: Kids Size Soft Moldable Silicone Putty Earplugs · McKeon Products, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    12

    Basic Information

    Brand Name
    Mack's
    Primary DI
    00033732000109
    Version / Model
    Kids Size Soft Moldable Silicone Putty Earplugs
    Catalog Number
    10
    Company Name
    McKeon Products, Inc.
    Labeler DUNS
    006522122
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2022-10-07
    Public Version
    1
    Public Version Date
    2022-10-17
    Public Version Status
    New
    Public Device Record Key
    1060aa1d-c714-48b2-bb62-b0380997e924

    Device Description

    Kids Size Silicone Earplugs - 6 pair box - Orange

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    EWD Protector, Hearing (Insert)

    GMDN Terms

    Code Name
    41230 Earplugs, reusable

    Identifiers

    Type ID
    Unit of Use 10033732000106
    Primary 00033732000109