BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOACCESS, INC.

    Reg #: 1124621 · FEI: 1000513050 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BIOACCESS, INC.
    Registration Number
    1124621
    FEI Number
    1000513050
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4000 HUDSON ST.
    City
    BALTIMORE
    State
    MD
    ZIP
    21224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K863734

    Owner / Operator

    Firm Name
    BIOACCESS, INC.
    Operator Number
    9031105
    Address
    4000 HUDSON ST., --
    City
    Baltimore
    State
    MD
    Postal Code
    21224
    Country
    US
    Correspondent
    ROBERT J CHAPOLINI

    Products

    Device Name Product Code
    Bur, Surgical, General & Plastic Surgery GFF
    Pin, Fixation, Smooth HTY
    Bone Marrow Collection/Transfusion Kit LWE

    Proprietary Names

    NGD-1005A, Next Gen Driver with chuck NGD-1000, Next Gen Driver SMALL BONE TOOL (SBT 1000 SBT 1004) SBT 1003 SBT 1001 BioAccess Traction Pin Kit BioAccess Marrow Collection System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility