(88 days)
Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices. The kits are to be enclose in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minutes dry-time.
Neodent Instruments Kits are intended for sterilization of non-porous loads.
The combined weight of GM EasyGuide Surgical Kit Case Narrow/Regular Diam Implants and the associated instruments is 310,18 g. The weight of the empty Kit Case is 263,63 g
Neodent GM EasyGuide Kit Cases should not be stacked during sterilization
Indications for Use for GM EasyGuide Surgical Kit Case Regular/Large Diam Implants:
Neodent Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instruments Kits are intended to allow sterilization of the enclosed medical devices. Neodent Instruments Kits require the use of FDA-cleared wrap to maintain the sterility of enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20 minutes dry-time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 45-minutes dry-time.
Neodent Instruments Kits are intended for sterilization of non-porous loads.
The combined weight of the GM EasyGuide Surgical Kit Case Regular/Large Diam Implants and the associated instruments is 346,45 g. The weight of the empty Kit Case is 264,12 g.
Neodent GM EasyGuide Kit Cases should not be stacked during sterilization.
The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices includes grommets manufactured from medical grade silicone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.
Here's a summary of the acceptance criteria and study information for the Neodent EasyGuide Kit Cases, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Performance Test / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Manual Cleaning Validation | ||
| Visual Inspection | No Visible Soil | No visible soil |
| Hemoglobin Test (against Blood Soil - BLSO) |
§ 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).