BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NIM-ECLIPSE®

    DI: 00763000102388 · Model: 945NCCPUE4 · MEDTRONIC SOFAMOR DANEK, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NIM-ECLIPSE®
    Primary DI
    00763000102388
    Version / Model
    945NCCPUE4
    Company Name
    MEDTRONIC SOFAMOR DANEK, INC.
    Labeler DUNS
    830350380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-30
    Public Version
    2
    Public Version Date
    2020-08-20
    Public Version Status
    Update
    Public Device Record Key
    ff278e6c-bc5f-435f-8717-6014f97b3a17

    Device Description

    COMPUTER 945NCCPUE4 LAPTOP

    Device Characteristics

    Single Use
    No
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GWF STIMULATOR, ELECTRICAL, EVOKED RESPONSE
    IYN System, imaging, pulsed doppler, ultrasonic

    GMDN Terms

    Code Name
    38453 Portable computer

    Identifiers

    Type ID
    Primary 00763000102388

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K061639 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius