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    FDA UDI In Commercial Distribution 🇺🇸 United States

    APEX 3D Total Ankle Replacement System

    DI: 00889795064004 · Model: P10-951-TPR1 · PARAGON 28, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    APEX 3D Total Ankle Replacement System
    Primary DI
    00889795064004
    Version / Model
    P10-951-TPR1
    Catalog Number
    P10-951-TPR1
    Company Name
    PARAGON 28, INC.
    Labeler DUNS
    042961576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-15
    Public Version
    2
    Public Version Date
    2021-10-19
    Public Version Status
    Update
    Public Device Record Key
    bd43d957-75c2-4ee4-a7fa-7a299df15e0b

    Device Description

    APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 1

    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
    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
    HTO REAMER

    GMDN Terms

    Code Name
    64337 Bone-coring punch, reusable

    Identifiers

    Type ID
    Primary 00889795064004