LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080307
    Device Name
    PROCHEM INDICATOR TAPE
    Manufacturer
    RAVEN LABORATORIES
    Date Cleared
    2008-05-01

    (86 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAVEN LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Raven ProChem Indicator Tape is a process chemical indicator tape intended to seal packs and provide visual evidence that packs have been exposed when subjected to steam sterilization (121°C gravity cycles and 121°C – 134°C pre-vacuum cycles) processes as well as Harvey Chemiclave® chemical vapor sterilization process.
    Device Description
    ProChem Indicator Tape is a saturated crepe paper printed with white indicator lines that turn to dark brown/black upon exposure to saturated steam or Chemiclave® chemical vapor sterilization. It is coated on the back with a dry natural rubber based adhesive for adherence to packs/packages.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1