BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sierra Summit

    DI: 00840067100264 · Model: 190292-200 · CADWELL INDUSTRIES, INC.
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sierra Summit
    Primary DI
    00840067100264
    Version / Model
    190292-200
    Company Name
    CADWELL INDUSTRIES, INC.
    Labeler DUNS
    098554157
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-08
    Public Version
    3
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    c95aac23-2516-4753-bbd1-4e52f56a89ef

    Device Description

    RING/BAR ELECTRODE SWITCH BOX

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWE Stimulator, photic, evoked response
    IKN Electromyograph, diagnostic
    JXE DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
    GWJ STIMULATOR, AUDITORY, EVOKED RESPONSE
    GZP STIMULATOR, MECHANICAL, EVOKED RESPONSE
    GWF STIMULATOR, ELECTRICAL, EVOKED RESPONSE

    GMDN Terms

    Code Name
    11474 Electromyograph

    Identifiers

    Type ID
    Primary 00840067100264

    Customer Contacts

    Phone
    +1(509)735-6481
    Email
    [email protected]