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510(k) Data Aggregation

    K Number
    K003087
    Device Name
    MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
    Manufacturer
    Date Cleared
    2000-11-07

    (41 days)

    Product Code
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPORICIDIN INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K983194
    Device Name
    SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
    Manufacturer
    Date Cleared
    1999-03-05

    (175 days)

    Product Code
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPORICIDIN INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. SSDS is intended for reprocessing only heat-sensitive medical devices. Sporicidin® Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions: | | Time | Temperature | |----------------------------|------------|--------------| | Sterilization | 12 hours | 25 degrees C | | High Level<br>Disinfection | 20 minutes | 25 degrees C | SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The glutaraldehyde MRC is 0.6%; the phenol MRC is 1.3%. Sporicidin Indicator Strips are intended for verifying the MRC of glutaraldehyde and phenol in SSDS during use. Sporicidin Indicator strips should be used before each use of SSDS.
    Device Description
    Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is a liquid chemical sterilant and high level disinfectant. The product contains two solutions: a buffer containing 1.7% phenol/phenate, and an activator containing 25% glutaraldehyde. When the two solutions are mixed, or activated, SSDS contains 0.95 % glutaraldehyde and 1.64% phenol/phenate. The solutions are combined at the user level, resulting in the activated germicide. SSDS is a liquid chemical sterilant and a high level disinfectant when used or reused according to the DIRECTIONS FOR USE included in the package insert. SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The MRC for glutaraldehyde is 0.6%, and 1.3% for phenol/phenate. Sporicidin® Sterilizing and Disinfecting Solution (SSDS) must be used with Sporicidin Indicator Strips, used to verify that the MRC of active ingredients is present. It is recommended that SSDS be tested with Sporicidin Indicator Strips prior to each use.
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