BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Safety Sponge

    Reg #: 8010177 · FEI: 3002821504 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    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
    K060076

    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
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Counter, Sponge, Surgical LWH

    Proprietary Names

    Safety Sponge SurgiCounter SurgiCount Tablet and Accessories

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)