BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PolyPrep

    DI: 00840124512863 · Model: CD-PP-2008-S · FUSION ORTHOPEDICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PolyPrep
    Primary DI
    00840124512863
    Version / Model
    CD-PP-2008-S
    Catalog Number
    CD-PP-2008-S
    Company Name
    FUSION ORTHOPEDICS, LLC
    Labeler DUNS
    080307067
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-07
    Public Version
    1
    Public Version Date
    2024-10-15
    Public Version Status
    New
    Public Device Record Key
    74202add-5d66-43db-8c83-b1c23d8402b6

    Device Description

    Pulling Cartilage Remover 8mm (Sterile)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QBO Instruments Designed For Press-Fit Osteochondral Implants

    GMDN Terms

    Code Name
    64557 Orthopaedic fixation plate file/rasp

    Identifiers

    Type ID
    Primary 00840124512863