BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Howard Leight

    DI: 00033552015178 · Model: Leight Plugs · SPERIAN HEARING PROTECTION, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Howard Leight
    Primary DI
    00033552015178
    Version / Model
    Leight Plugs
    Catalog Number
    R-01517
    Company Name
    SPERIAN HEARING PROTECTION, LLC
    Labeler DUNS
    014982953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    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
    6d4b24bd-26f8-414a-b334-35051ecbf23b

    Device Description

    Leight Plugs Low Pressure Single-Use Foam Earplugs - 5 Pair With Carrying Case

    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
    Primary 00033552015178