BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELUTIA INC.

    Reg #: 3031160994 · FEI: 3031160994 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELUTIA INC.
    Registration Number
    3031160994
    FEI Number
    3031160994
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    20 Firstfield Rd
    City
    Gaithersburg
    State
    MD
    ZIP
    20878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140789

    Owner / Operator

    Firm Name
    Elutia Inc.
    Operator Number
    10055257
    Address
    20 Firstfield Road
    City
    Gaithersburg
    State
    MD
    Postal Code
    20878
    Country
    US
    Correspondent
    Erica Elchin

    Products

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

    Proprietary Names

    ECM for Vascular Repair VasCure for Vascular Repair ECM for Carotid Repair VasCure for Carotid Repair ECM for Pericardial Closure ProxiCor for Pericardial Closure Tyke ECM for Cardiac Tissue Repair ProxiCor for Cardiac Tissue Repair

    Establishment Types

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