BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Inner Ear Valved Shunt

    DI: 00815347023588 · Model: EA-1001 · HOOD, E BENSON LABORATORIES INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Inner Ear Valved Shunt
    Primary DI
    00815347023588
    Version / Model
    EA-1001
    Company Name
    HOOD, E BENSON LABORATORIES INC
    Labeler DUNS
    076603380
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-07
    Public Version
    4
    Public Version Date
    2023-11-22
    Public Version Status
    Update
    Public Device Record Key
    9714f4bb-4116-4a46-a391-f927ff1ef9ba
    Distribution End Date
    2023-08-14

    Device Description

    Arenberg Inner Ear Valve Shunt

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

    Product Codes

    Code Name
    ESZ Tube, Shunt, Endolymphatic

    GMDN Terms

    Code Name
    42422 Nasopharyngeal airway, single-use

    Identifiers

    Type ID
    Primary 00815347023588