BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ReLine

    DI: 00887517948748 · Model: 10001136 · Nuvasive, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ReLine
    Primary DI
    00887517948748
    Version / Model
    10001136
    Company Name
    Nuvasive, Inc.
    Labeler DUNS
    053950783
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-23
    Public Version
    1
    Public Version Date
    2020-05-01
    Public Version Status
    New
    Public Device Record Key
    b7e4dfb8-0c97-4a8c-b3af-a059e2de3bbc

    Device Description

    RELINE-O Pusher, Fenestrated

    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
    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
    NKB Thoracolumbosacral pedicle screw system
    PML bone cement, posterior screw augmentation
    KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    GMDN Terms

    Code Name
    61300 Internal spinal fixation procedure kit, single-use

    Identifiers

    Type ID
    Primary 00887517948748

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K180498 000