BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SporView Steam Self-Contained Biological Indicator, SCS-025, SCS-100

    Reg #: 1319130 · FEI: 1319130 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Crosstex International
    Registration Number
    1319130
    FEI Number
    1319130
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6789 WEST HENRIETTA RD.
    City
    Rush
    State
    NY
    ZIP
    14543
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111515

    Owner / Operator

    Firm Name
    SPS/Crosstex International
    Operator Number
    1319130
    Address
    1666 E Touhy Ave
    City
    Des Plaines
    State
    IL
    Postal Code
    60018
    Country
    US

    Products

    Device Name Product Code
    Indicator, Biological Sterilization Process FRC

    Proprietary Names

    SporView Steam Self-Contained Biological Indicator, SCS-025, SCS-100 SporView@ Steam Self-Contained Biological Indicator, SCS-100 (Private labels BI-038, 6005500522)

    Establishment Types

    Repack or Relabel Medical Device