BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MACI Implantation

    Reg #: 1226230 · FEI: 3002836339 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Vericel Corporation
    Registration Number
    1226230
    FEI Number
    3002836339
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    64 Sidney St
    City
    CAMBRIDGE
    State
    MA
    ZIP
    02139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171520

    Owner / Operator

    Firm Name
    Vericel
    Operator Number
    10051107
    Address
    64 Sidney Street
    City
    Cambridge
    State
    MA
    Postal Code
    02139
    Country
    US
    Correspondent
    Gina Prochilo-Cawston

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    MACI Implantation Vericel Surgical Implantation Surgical Implantation

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility