BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Precice External Remote Controller

    DI: 00195377097309 · Model: SW0011 · NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Precice External Remote Controller
    Primary DI
    00195377097309
    Version / Model
    SW0011
    Catalog Number
    SW0011
    Company Name
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Labeler DUNS
    837845234
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-29
    Public Version
    1
    Public Version Date
    2021-11-08
    Public Version Status
    New
    Public Device Record Key
    814f4666-16d5-4c0f-ba1a-c2f4a73593cc

    Device Description

    PRECICE Prescription Program

    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
    HSB Rod, Fixation, Intramedullary And Accessories

    GMDN Terms

    Code Name
    43538 Distraction plate/rod adjustment remote control

    Identifiers

    Type ID
    Primary 00195377097309

    Customer Contacts

    Phone
    855-435-5477
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K131490 000