BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3-D MATRIX, INC.

    Reg #: 3015528146 · FEI: 3015528146 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    3-D MATRIX, INC.
    Registration Number
    3015528146
    FEI Number
    3015528146
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1234 Chestnut St., Suite 205
    City
    Newton
    State
    MA
    ZIP
    02464
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222481

    Owner / Operator

    Firm Name
    3D-Matrix
    Operator Number
    10060325
    Address
    1234 Chestnut St., Suite 205, Suite 205
    City
    Newton
    State
    MA
    Postal Code
    02464
    Country
    US
    Correspondent
    Alan G Miskewicz

    Products

    Device Name Product Code
    Connector, Catheter GCD
    Hemostatic Device For Endoscopic Gastrointestinal Use QAU
    Polymer, Ear, Nose And Throat, Synthetic, Absorbable NHB
    Protective Coating, Mucoadhesive Application, For The Rectal Mucosa PHN
    Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic MGQ
    Oral Wound Dressing OLR

    Proprietary Names

    Syringe Adapter PuraStat PuraGel PuraSinus PuraGel; PuraSinus - Oral Mucosa

    Establishment Types

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