(29 days)
The packaging tray is intended to be used as a non-reusable protective pack, which allows EO sterilization of the product and maintains sterility for a specified length of time, and protects the product from damage during transport, delivery and storage.
Packaging Tray and Accessories
This is a 510(k) clearance letter for a "Packaging Tray and Accessories" (K040707) and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from this document. This letter is an administrative approval of market clearance, not a performance study report.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).