BEUDAMED
    67 results · 52ms · Sources: EU EUDAMED, US FDA

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    Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 1, 2015

    STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 3, 2013

    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·September 5, 2012

    STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 22, 2014

    STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 22, 2014

    STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 22, 2014

    STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·October 30, 2013

    STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 4, 2013

    STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 4, 2013

    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 16, 2013

    STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 31, 2014

    EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 18, 2017

    STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 31, 2014

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·May 8, 2013

    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·September 23, 2015

    STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 31, 2014

    STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 31, 2014

    STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 8, 2014

    STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 31, 2014