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U.S. Department of Health and Human Services

Product Classification

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Device sterilizer automated loading system
Regulation Description Steam sterilizer.
Definition Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.
Physical State The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and a sterilizer that sits on a loading car.
Technical Method Works in conjunction with a steam sterilizer
Target Area NA
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePEC
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.6880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons