Catalog of Class II Medical Devices Exempted from Clinical Trials
Serial No.
Product Name
Classification Code
Product Description
1 Medical Suture Needle 6801
Medical suture needles are usually made of stainless steel wire without thread, and are used according to the shape of the needle ( Such as round, triangular, anti-triangular, short-bladed triangular, triangular half-curved, etc.), curvature (straight, 1/2 arc, 3/8 arc, etc.), hole (ordinary hole, bullet hole), etc. are divided into a number of different types, each type is divided into a number of specifications according to the diameter of the needle, chord length, etc.; to provide aseptic or non-sterile form; for the closure of viscera, hard and soft tissues, skin use. The product performance index adopts the applicable part of the following reference standards, e.g. YY 0043-2005 Medical Suture Needles. 2 Disposable surgical blades 6801
Disposable surgical blades are made of carbon tool steel or alloy tool steel and other materials suitable for making blades, which can contain a handle; the blades are divided into a number of different types according to the different types, each of which can be divided into a number of specifications according to the different sizes of the matching handle and blades; the products are provided in the form of aseptic; they are used for cutting soft tissues. The performance index of the product adopts the applicable part of the following reference standards, such as: YY 0174-2005 surgical blades, GB 8662-2006 surgical blades and surgical knife handle with the size.
3 Disposable umbilical cord cutter and clamp 6801
Disposable umbilical cord cutter and clamp is usually made of polymer material (e.g., polyethylene, etc.) and metal material (e.g., austenitic stainless steel for the blade), and it can be composed of umbilical cord clamp and cutter, retention umbilical cord clamp, and accessory parts, etc. It is provided in a sterile form for cutting off and sealing umbilical cord remnants of newborns.
4
Disposable Surgical Electrode Cleaning Sheet
6801
Disposable surgical electrode cleaning sheet can be composed of (sponge) base layer, (SiO2, etc.) fine abrasive layer, pressure-sensitive adhesive layer, (barium wire) developer line, (silicone oil) isolation paper, according to the different shapes and sizes are divided into a number of specifications; to provide aseptic form; for the surgery of For cleaning burnt tissue and other adherents on high-frequency surgical electrodes.
No. Product Name Classification Code Product Description
5
Disposable Surgical Instruments for Finger Manipulation
6801
Disposable Surgical Instruments for Finger Manipulation consists of a polycarbonate cannula and a stainless steel end-effector, which can be classified into a number of models and specifications according to the design, technical parameters, and the intended use; provided in sterile form; used for colonics. sterile form; used for grasping, moving, separating, cutting and suturing tissues in colorectal, urological, gynecological and other laparoscopic surgery (HALS) and open surgery.
6 Disposable surgical irrigation needles 6802
Disposable surgical irrigation needles are made of applicable polymer and metal materials, consisting of needle holder and flat head syringe, which can be divided into several models and specifications according to the material, capacity and diameter of the needle, etc.; provided in a sterile form; used in conjunction with syringes for microsurgery, ophthalmology, stomatology, orthopedics and other surgical operations for irrigation. It is supplied in sterile form.
7 Intracerebral scissors 6803
Intracerebral scissors are made of metal, consisting of handle and head, single joint, the head of the knife can be designed to be straight, up and down curved, etc., the handle and the head can be made into a certain two-dimensional or three-dimensional angle, in order to adapt to different anatomical position of the operation, the head of the knife can not end for the pointed or blunt, smooth surface, do not damage the surrounding tissues; according to the different materials, design, technical parameters, expected It can be divided into several models and specifications according to the material, design, technical parameters, intended use, etc.; it is usually a repeatable instrument; it is used for cutting out diseased bone or necrotic nerve/brain tissue during intracerebral surgery.
8 intracerebral forceps 6803
The intracerebral forceps are made of metal, consisting of a handle and a head, single joint, the head can be designed as a straight, left and right curved, etc., the handle and the head can be made into a certain two-dimensional or three-dimensional angle, in order to adapt to different anatomical position of the operation, the head of the forceps can be round or oval or other shapes, the surface is smooth, does not damage the surrounding tissues; can be divided into a number of models according to different materials, designs, technical parameters, intended use and so on. The clamp can be divided into several models and specifications according to the material, design, technical parameters, intended use, etc. It is usually a repeatable instrument; it is used for intracerebral surgery to clip intracranial tumors and pericardium.
9 Intracerebral forceps 6803
The intracerebral forceps are made of metal, consisting of a shank and a head, the tip of the head can be designed as a thin or rounded, the shank and the head can be formed into a certain two-dimensional angle, the shank has a non-slip convex design, smooth surface, not to damage the surrounding tissues; according to the material, design, technical parameters, the intended use and so on, can be divided into a number of different models and specifications; usually for repeatable instruments. It is used for intracerebral surgery to clip dressings and soft tissues in the brain.