BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SYNCRO MEDICAL INNOVATIONS, INC.

    Reg #: 1066607 · FEI: 3003282547 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SYNCRO MEDICAL INNOVATIONS, INC.
    Registration Number
    1066607
    FEI Number
    3003282547
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    101 Gateway Dr
    City
    Macon
    State
    GA
    ZIP
    31210
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201741

    Owner / Operator

    Firm Name
    SYNCRO MEDICAL INNOVATIONS, INC.
    Operator Number
    9045267
    Address
    101 Gateway Dr
    City
    Macon
    State
    GA
    Postal Code
    31210
    Country
    US
    Correspondent
    Sabry - Gabriel

    Products

    Device Name Product Code
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Tubes, Gastrointestinal (And Accessories) KNT
    Bag, Urine Collecting, Ureterostomy EXG

    Proprietary Names

    Gabriel 3-Way EnFit Valve Gabriel Feeding Tube with Balloon Gabriel Feeding Tube with Balloon, and EnFit Connector Gabriel® Urine Bag

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility