BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PRECICE® Instruments

    DI: 00812258028855 · Model: PGA1-002 · NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PRECICE® Instruments
    Primary DI
    00812258028855
    Version / Model
    PGA1-002
    Catalog Number
    PGA1-002
    Company Name
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Labeler DUNS
    837845234
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-30
    Public Version
    3
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    c3c251ed-072d-44f9-9c5a-ff062cdb6134

    Device Description

    Orthopedic surgical instrument - Targeting Arm Tibia, UNYTE/Short

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    HSB Rod, Fixation, Intramedullary And Accessories

    GMDN Terms

    Code Name
    38152 Tibia nail

    Identifiers

    Type ID
    Primary 00812258028855

    Customer Contacts

    Phone
    855-435-5477
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Tool/Instrument