BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Simplify® Cervical Artificial Disc

    DI: 00843285100696 · Model: E · Nuvasive, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Simplify® Cervical Artificial Disc
    Primary DI
    00843285100696
    Version / Model
    E
    Catalog Number
    T-MD-4
    Company Name
    Nuvasive, Inc.
    Labeler DUNS
    053950783
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-14
    Public Version
    3
    Public Version Date
    2022-02-04
    Public Version Status
    Update
    Public Device Record Key
    a4ba78f9-47d9-4da2-ae6c-c21e830eddd9

    Device Description

    Simplify® Trial, Size MD, Height 4

    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
    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MJO Prosthesis, Intervertebral Disc

    GMDN Terms

    Code Name
    44788 Spinal implant trial

    Identifiers

    Type ID
    Primary 00843285100696

    Customer Contacts

    Phone
    +1(858)909-1800
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P200022 000

    Device Sizes

    Type Value Unit Text
    Height 4 Millimeter