BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SPG Bulb Drainage System

    Reg #: 8010177 · FEI: 3002821504 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER LEIBINGER GMBH & CO. KG
    Registration Number
    8010177
    FEI Number
    3002821504
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BOTZINGER STRASSE 39-41
    City
    FREIBURG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K833586

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY

    Proprietary Names

    SPG Bulb Drainage System TLS Bulb Drainage System

    Establishment Types

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