BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MACI Surgical Implantation Kit

    DI: 00850037506132 · Model: N/A · VERICEL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MACI Surgical Implantation Kit
    Primary DI
    00850037506132
    Version / Model
    N/A
    Company Name
    VERICEL CORPORATION
    Labeler DUNS
    079745570
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-09
    Public Version
    1
    Public Version Date
    2022-11-17
    Public Version Status
    New
    Public Device Record Key
    127c741e-c24c-43fa-aa6b-5ac48fcb0d3d

    Device Description

    The MACI Surgical Implantation Kit is intended to assist with MACI® (autologous cultured chondrocytes on porcine collagen membrane) knee surgery. The kit contains instruments to assist surgeons with preparing the defect, cutting the implant, and transferring the implant. The MACI Surgical Implantation Kit contains: 1 - Sterilization Tray; 1 - Silicone Cutting Block, Single Use Only; 1 - Tungsten Carbide Scissors (32-705), manufactured by Symmetry Surgical, Inc.; 2 - Toothless Adsons (30-1185), manufactured by Symmetry Surgical, Inc.; 1 - 4.5mm Ring Curette (8435.902), manufactured by Richard Wolf Medical Instruments Corp.; 1 - 6.0mm Ring Curette (8435.903), manufactured by Richard Wolf Medical Instruments Corp.; 1 - Mallet (FL072K), manufactured by Aesculap, Inc.; 1 - Cutter Oval 13X20mm (FR730R), manufactured by Aesculap, Inc.; 1 - Cutter Oval 15X23mm (FR731R), manufactured by Aesculap, Inc.; 1 - Cutter Oval 20X25mm (FR722R), manufactured by Aesculap, Inc.; 1 - Cutter Oval 22X32mm (FR723R), manufactured by Aesculap, Inc.; 1 - Cutter Round D15mm (FR721R), manufactured by Aesculap, Inc.; 1 - Cutter Round D28mm (FR737R), manufactured by Aesculap, Inc.; 1 - Cutter Oblong 10X30mm (FR738R), manufactured by Aesculap, Inc.;

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    FSM Tray, Surgical, Instrument

    GMDN Terms

    Code Name
    44054 Orthopaedic surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary 00850037506132