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510(k) Data Aggregation
K Number
K241123Device Name
Perpak Sterilization Tyvek Pouch
Manufacturer
Date Cleared
2024-09-18
(148 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
KM Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perpak™ Sterilization Tyvek Pouch is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the LOWTEM Crystal 120 Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.
Device Description
The Perpak™ Sterilization Tyyek Pouch is intended to be used to contain medical devices to be terminally sterilized in the LOWTEM Crystal 120 Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the LOWTEM Crystal 120 Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains sterility of the enclosed medical devices until the seal is opened up to 3 years post sterilization.
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