BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PRECICE® System

    DI: 00887517940704 · Model: PFD1-000 · NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PRECICE® System
    Primary DI
    00887517940704
    Version / Model
    PFD1-000
    Catalog Number
    PFD1-000
    Company Name
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Labeler DUNS
    837845234
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-11
    Public Version
    4
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    f58fc53b-745f-4be8-b01f-857810b4cd16

    Device Description

    PRECICE Fast Distractor

    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
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HWN Instrument, Compression

    GMDN Terms

    Code Name
    63368 Distraction plate/rod preimplantation adjustment device

    Identifiers

    Type ID
    Primary 00887517940704

    Customer Contacts

    Phone
    855-435-5478
    Email
    [email protected]

    Device Sizes

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