BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vericel Corporation

    Reg #: 1226230 · FEI: 3002836339 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    35
    Establishment Types
    4
    Classifications
    14

    Registration Details

    Registration Name
    Vericel Corporation
    Registration Number
    1226230
    FEI Number
    3002836339
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    64 Sidney St
    City
    CAMBRIDGE
    State
    MA
    ZIP
    02139
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK050036

    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
    Tape, Measuring, Rulers And Calipers FTY
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Accessories, Arthroscopic NBH
    Media And Components, Synthetic Cell And Tissue Culture KIT
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Container, Specimen Mailer And Storage, Temperature Controlled, Sterile KDW
    Cultured Epithelial Autograft OCE
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Tray, Surgical, Instrument FSM
    Passer HWQ
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Tamp HXG
    Cutter, Surgical FZT
    Instrument, Surgical, Disposable KDC

    Proprietary Names

    Arthroscopic Measurement Probe BD Vacutainer EDTA (K2) Blood Collection Tubes 15mm x 4cm Cannula Assembly 15mm x 3cm Cannula Assembly 14mm x 26mm Max Arthroscopic Cutter 18mm x 4cm Cannula Assembly 3.6mm Rake Curette 4mm x 5mm Square Curette 14mm x 26mm Min Arthroscopic Cutter 17mm x 28mm Max Arthroscopic Cutter 12mm x 21mm Min Arthroscopic Cutter 6.5mm Open-Ring Curette Skin Biopsy Transport Medium Cartilage Biopsy Transport Medium Vericel Surgical Implantation Surgical Implantation MACI Implantation Cartilage Biopsy Transport Kit Skin Biopsy Transport Kit cultured epithelial autograft Vonco 95kPa VonSeal MACI Implantation Kit Vericel Surgical Implantation Kit MACI Surgical Implantation Kit 18mm V-Shuttle Delivery Device 15mm V-Shuttle Delivery Device Blood Collection Kit MACI Applicators, Two-Pack MACI Applicator 12mm x 21mm MACI Cutter 17mm x 28mm MACI Cutter 14mm x 26mm MACI Cutter Cutting Block MACI Cutting Block MACI Arthroscopic Cutting Block

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility