BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NuFix

    DI: B946NF1001S0 · Model: IR · Nutech Spine, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NuFix
    Primary DI
    B946NF1001S0
    Version / Model
    IR
    Catalog Number
    NF-1001S
    Company Name
    Nutech Spine, Inc.
    Labeler DUNS
    080867996
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-24
    Public Version
    2
    Public Version Date
    2023-04-21
    Public Version Status
    Update
    Public Device Record Key
    bf671c8d-32d2-452a-b115-051f46ea6f26

    Device Description

    Stainless Steel Facet Locator

    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
    No
    PM Exempt
    Yes
    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
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    42848 External spinal fixation system

    Identifiers

    Type ID
    Primary B946NF1001S0