BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 00385640033718 · Model: J-1084A · Summit Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    00385640033718
    Version / Model
    J-1084A
    Company Name
    Summit Medical, Inc.
    Labeler DUNS
    965484699
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-13
    Public Version
    4
    Public Version Date
    2021-08-23
    Public Version Status
    Update
    Public Device Record Key
    4b02033e-608f-48fa-8682-01be63c85127

    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
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KCN Ear Wick

    GMDN Terms

    Code Name
    33468 Ear wick, non-biodegradable

    Identifiers

    Type ID
    Primary 00385640033718
    Package 10385640033715