BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    B3 GEL™ System

    · Expires 2025
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TYBR HEALTH, INC.
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2450 Holcombe Blvd Ste X
    City
    Houston
    State
    TX
    ZIP
    77021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250109

    Owner / Operator

    Firm Name
    TYBR Health, Inc.
    Operator Number
    10093752
    Address
    2450 Holcombe Blvd, Suite X
    City
    Houston
    State
    TX
    Postal Code
    77021
    Country
    US
    Correspondent
    Timothy J Keane

    Products

    Device Name Product Code
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Mesh, Surgical FTM

    Proprietary Names

    B3 GEL™ System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility