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510(k) Data Aggregation
K Number
K112671Device Name
STERILCONTAINER SYSTEM
Manufacturer
AESCULAP, LTD.
Date Cleared
2012-05-04
(233 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
AESCULAP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aesculap SterilContainer System is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
Device Description
The Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. There are a variety of accessories also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO sterilization. The container bottom is manufactured in anodized aluminum and has stainless steel handles on each end. There are two types of lids for the container bottom. There are anodized aluminum lids that have removable retention plates to hold the filter and a stainless steel latch on each end to lock the lid only to the container bottom. There are also Prime Line lids available for use that are manufactured in the material commonly known as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is for Pre-vac steam and Immediate Use steam sterilization only.
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