BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ProCell Surgical Sponge-Blood Recovery Unit

    Reg #: 3016994551 · FEI: 3016994551 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PROCELL SURGICAL INC.
    Registration Number
    3016994551
    FEI Number
    3016994551
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    780 Dedham St, Suite 700
    City
    Canton
    State
    MA
    ZIP
    02021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193361

    Owner / Operator

    Firm Name
    ProCell Surgical Inc.
    Operator Number
    10075210
    Address
    780 Dedham St, Suite 700
    City
    Canton
    State
    MA
    Postal Code
    02021
    Country
    US
    Correspondent
    Anne Bolin

    Products

    Device Name Product Code
    Apparatus, Autotransfusion CAC

    Proprietary Names

    ProCell Surgical Sponge-Blood Recovery Unit

    Establishment Types

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