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The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).

The Sterile Aesthetic Cannula and Hypodermic Needle is a combined medical device, including a blunt needle-cannula and a hypodermic needle. The sharp needle consists of a needle hub, a needle, and a protective cap. The blunt needle-cannula consists of a needle hub, a blunt cannula, and a protective cap. The device is provided for single-used, sterilized, and prescription use only. It offers various model configurations, including multiple needle gauge sizes, lengths, and tips, to fit most usage scenarios.

This document does not contain an AI/ML device. Therefore, the requested information elements related to AI/ML device performance, such as acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable and cannot be extracted.

The document describes a Sterile Aesthetic Cannula and Hypodermic Needle (K223327), which is a conventional medical device. The information provided is primarily about its physical and biological performance testing to demonstrate substantial equivalence to a predicate device.

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