BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Howard Leight

    DI: 00033552003717 · Model: MAX · SPERIAN HEARING PROTECTION, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    Howard Leight
    Primary DI
    00033552003717
    Version / Model
    MAX
    Catalog Number
    MAX-1-D
    Company Name
    SPERIAN HEARING PROTECTION, LLC
    Labeler DUNS
    014982953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2020-07-31
    Public Version
    2
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    fde7f388-69c0-4c8b-a96d-062c0a7d59b7

    Device Description

    MAX-1 D Earplugs Cordless 33 NRR Coral LS 500 Refill

    Device Characteristics

    Single Use
    Yes
    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
    35024 Earplugs, single-use

    Identifiers

    Type ID
    Unit of Use 10033552003714
    Primary 00033552003717