BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    High Lighter

    DI: G225SS1DBS0 · Model: SS1-DBS · Pathcom Systems Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    High Lighter
    Primary DI
    G225SS1DBS0
    Version / Model
    SS1-DBS
    Company Name
    Pathcom Systems Corporation
    Labeler DUNS
    845346506
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-04-29
    Public Version
    2
    Public Version Date
    2022-05-20
    Public Version Status
    Update
    Public Device Record Key
    fc650ffc-dcd1-462d-b03d-ee9abf195350
    Distribution End Date
    2022-05-20

    Device Description

    The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPA Slide Stainer, Automated

    GMDN Terms

    Code Name
    15599 Microscope slide stainer IVD

    Identifiers

    Type ID
    Primary G225SS1DBS0