BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Enterra® II

    DI: 00643169360686 · Model: 37800 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Enterra® II
    Primary DI
    00643169360686
    Version / Model
    37800
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    796986144
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-10-03
    Public Version
    4
    Public Version Date
    2023-10-16
    Public Version Status
    Update
    Public Device Record Key
    55731b39-64f6-4c18-bc89-2e2dbcc812af

    Device Description

    INS 37800 ENTERRA II NEUROSTIMULATOR

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LNQ intestinal Stimulator

    GMDN Terms

    Code Name
    48001 Gastric electrical stimulation system

    Identifiers

    Type ID
    Primary 00643169360686

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -30 – 135 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    -34 – 57 Degrees Celsius