Class II medical devices exempted from clinical trials
serial number
product name
Classification coding
product description
1 medical suture needle 680 1
Medical suture needle is usually made of stainless steel wire without thread, and it can be divided into several types according to the shape of the needle (such as circle, regular triangle, inverted triangle, short triangle, triangular semi-bend, etc.). ), radian (straight line, 1/2 arc, 3/8 arc, etc. ), pinhole (ordinary hole, elastic machine hole), etc. Each type is divided into several types according to the needle diameter and chord length. Provided in sterile or non-sterile form; Used for suturing internal organs, soft and hard tissues and skin. The product performance index adopts the applicable parts of the following reference standards, such as YY 0043-2005 medical suture needle. 2 disposable surgical blade 680 1
Disposable surgical blades are made of carbon tool steel or alloy tool steel and other materials suitable for making blades, and may include handles; Blade can be divided into several types according to different types, and each type can be divided into several specifications according to the size of the supporting handle and blade. Products are provided in aseptic form; Used for cutting soft tissue. The product performance index adopts the applicable parts of the following reference standards, such as YY 0 174-2005 Surgical Blade and GB 8662-2006 Matching Dimensions of Surgical Blade and Surgical Handle.
3 disposable umbilical cord scissors 680 1
Disposable umbilical cord forceps are usually made of polymer materials (such as polyethylene). ) and metal materials (such as blades made of austenitic stainless steel), which can be composed of umbilical clamp, indwelling umbilical clamp and accessories. It is provided in a sterile form for cutting and sealing the umbilical cord stump of newborns.
four
Disposable surgical electrode cleaning sheet
680 1
Disposable surgical electrode cleaning sheet can be composed of (sponge) base layer, (silicon dioxide) and so on. Fine abrasive layer, pressure-sensitive adhesive layer, (barium line) developing line and (silicone oil) release paper are divided into several specifications according to different shapes and sizes. Provided in sterile form; Used to clean charred tissue and other attachments on electrodes of high frequency surgery during operation.
Serial number Product name Classification coding Product description
five
Disposable surgical instrument with finger exercise function
680 1
Disposable finger-operated surgical instruments are composed of polycarbonate sleeve and stainless steel end effector, which can be divided into various models and specifications according to design, technical parameters and expected use. Provided in sterile form; It is used for grasping, moving, separating, cutting and suturing tissues in laparoscopic surgery (HALS) and open surgery in colorectal surgery, urology and gynecology.
Disposable surgical irrigation needle 6802
Disposable surgical irrigation needles are made of suitable polymer materials and metal materials, consisting of needle holders and flat-headed needle tubes, and can be divided into several models and specifications according to different materials, capacities and needle diameters. Provided in sterile form; It can be used together with syringe for wound irrigation in microsurgery, ophthalmology, stomatology and plastic surgery.
7 brain scissors 6803
The brain scissors are made of metal, and consist of a handle and a head, with only one joint. The cutter head can be designed to be straight, curved up and down, etc. The handle and head can form a certain two-dimensional or three-dimensional angle to adapt to the operation of different anatomical positions, and the tip of the knife can be sharp or blunt, with a smooth surface and no damage to surrounding tissues. According to different materials, designs, technical parameters and expected uses, it can be divided into several models and specifications. Usually a repeatable instrument; It is used to remove diseased bones or necrotic nerve/brain tissue in brain surgery.
8 Intracerebral forceps 6803
The brain clamp is made of metal, which consists of a handle and a head, and has only one joint. The pliers head can be designed to be straight, curved left and right, etc. The handle and the forceps head can form a certain two-dimensional or three-dimensional angle to adapt to the operation of different anatomical positions. The end of the forceps head can be round, oval or other shapes, with smooth surface and no damage to surrounding tissues. According to different materials, designs, technical parameters and expected uses, it can be divided into several models and specifications. Usually a repeatable instrument; It is used to clamp intracranial tumor and capsule in brain surgery.
9 brain forceps 6803
Brain forceps are made of metal and consist of a handle and a head. The tip of the head can be designed as a cone or a circle, and the handle and the head can form a certain two-dimensional angle. The handle adopts anti-slip concave-convex design, with smooth surface and no damage to surrounding tissues. According to different materials, designs, technical parameters and expected uses, it can be divided into several models and specifications. Usually a repeatable instrument; It is used to clamp the dressing and soft tissue in the brain during brain surgery.