BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Oto Ease 12pk Display Box

    DI: 00850047788115 · Model: NA · Westone Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Oto Ease 12pk Display Box
    Primary DI
    00850047788115
    Version / Model
    NA
    Catalog Number
    54011
    Company Name
    Westone Laboratories, Inc.
    Labeler DUNS
    007087497
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-02
    Public Version
    2
    Public Version Date
    2024-02-15
    Public Version Status
    Update
    Public Device Record Key
    7fb6208c-a78c-426c-8dd1-01979a09c2f8
    Distribution End Date
    2024-02-01

    Device Description

    Earmold Lubricant

    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KMJ Lubricant, Patient

    GMDN Terms

    Code Name
    60796 General-body orifice lubricant

    Identifiers

    Type ID
    Primary 00850047788115