BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spirus Medical, LLC

    Reg #: 3005814162 · FEI: 3005814162 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Spirus Medical, LLC
    Registration Number
    3005814162
    FEI Number
    3005814162
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    375 West St
    City
    W Bridgewater
    State
    MA
    ZIP
    02379
    Country
    US

    Regulatory Submissions

    510(k) Number
    K052084

    Owner / Operator

    Firm Name
    Spirus Medical, LLC
    Operator Number
    10022943
    Address
    375 West St
    City
    West Bridgewater
    State
    MA
    Postal Code
    02379
    Country
    US
    Correspondent
    Daniel A Massucco

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Lubricant, Patient KMJ
    Enteroscope And Accessories FDA
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    Endo-Ease Advantage Endo-Ease Vista Endo-Ease Discovery SB Spirus Medical Lubricant

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility