BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ECM for Cardiac Tissue Repair

    Reg #: 3005619880 · FEI: 3005619880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Elutia Inc.
    Registration Number
    3005619880
    FEI Number
    3005619880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1100 Old Ellis Rd, Suite 1200
    City
    Roswell
    State
    GA
    ZIP
    30076
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063349

    Owner / Operator

    Firm Name
    Elutia Inc.
    Operator Number
    10055257
    Address
    1100 Old Ellis Road, Suite 1200
    City
    Roswell
    State
    GA
    Postal Code
    30076
    Country
    US
    Correspondent
    Mike Hennick

    Products

    Device Name Product Code
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ

    Proprietary Names

    ECM for Cardiac Tissue Repair ProxiCor for Cardiac Tissue Repair

    Establishment Types

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