Serial number classification coding product name product description category
1 0 1-02-02 medical laser fiber is composed of laser connector, optical fiber transmitter and application end. After being connected with a laser, it is used to transmit laser for laser surgery. The light-emitting end of the optical fiber is a straight cut end face. Ⅱ
2 0 1-02-02 disposable intranasal irradiation optical fiber head is composed of laser connector, optical fiber and patient end, and the patient end is U-shaped. After connecting with a suitable laser, the laser is transmitted to the nasal cavity to irradiate the capillaries in the nasal cavity. Ⅱ
3 0 1-03-0 1 High-frequency cautery The high-frequency cautery consists of a main machine, various therapeutic instruments and accessories. Usually, its rated frequency and output power are much lower than that of high-frequency surgical equipment, and it can be divided into several models according to different designs, types, technical parameters and expected uses. Only used in dermatology, otolaryngology, gynecology, anorectal superficial surgery, so that the corresponding tissue coagulation degeneration and/or necrosis. Ⅱ
4 0 1-03-0 1 High-frequency surgical equipment usually includes high-frequency generator host and other related accessories (foot switch, surgical electrode, neutral electrode, etc.). ); High-frequency current (frequency range 200 K-5 MHz) directly flows through the human body to produce thermal effect, so as to cut and coagulate human tissues conventionally. It is used for conventional cutting and coagulation of human tissues in traditional electrosurgery. The frequency range of high frequency generator should be limited to 200 K-5 MHz specified in GB 9706.4; The scope of application is limited to routine tissue cutting and coagulation surgery (general surgery, otolaryngology, neurosurgery, gynecology, laparoscopic surgery, etc.). ); It does not include special clinical applications or ways of use, such as plasma cutting and coagulation, great vessel sealing, etc. Ⅲ
5 0 1-03-03 sterile pipeline high-frequency connector sterile pipeline high-frequency connector adopts high-frequency radiation heating method to realize aseptic connection between two polymer sterile pipelines; The instrument usually consists of a high frequency generator, an output and a controller. Sterile pipes with different diameters can be heat-sealed by means of dies. Used for sealing sterile pipelines such as infusion pipelines in clinical field. Ⅱ
6 0 1-03-03 argon controller includes controller, argon pen and other accessories; The high-pressure argon in the high-purity argon bottle is converted into the adjustable small-flow argon required by the work through the gas pressure reducing valve and the argon control module, and the argon knife is matched with the high-frequency knife to form the argon knife; Combined with high frequency electrotome, coagulation in argon environment can be realized in electrosurgery. Ⅲ
7 0 1-03-04 cathode plate for disposable high-frequency surgical equipment The cathode plate for disposable high-frequency surgical equipment is usually composed of separator paper, conductive adhesive, aluminum foil, substrate (such as polyethylene foam or non-woven fabric coated with acrylic pressure-sensitive adhesive) and electrode wires. According to the conductive medium (metal electrode conductive/ionic conductive adhesive conductive), users (adults/children), electrode number (unipolar/bipolar) and The product performance index adopts the applicable parts of the following reference standards, such as: GB 9706.4 Medical electrical equipment Part 2-2: Special requirements for the safety of high-frequency surgical equipment. Ⅱ
8 0 1-03-04 High-frequency surgical electrode (electrosurgical pen, electrocoagulation forceps, electrocoagulation scissors, electrocoagulation forceps) The high-frequency surgical electrode is an accessory of high-frequency surgical equipment, which usually consists of a high-frequency plug, a high-frequency wire and a handheld working end (which may include a handle, a manual switch/pedal, a single/bipolar metal electrode head and a cooling water supply system). Can be provided in sterilized/unsterilized form; Combined with high-frequency surgical equipment, it can be used for tissue cutting, separation, blood vessel clamping and hemostasis, tissue coagulation and so on. In various clinical open surgical procedures. The product performance index adopts the applicable parts of the following reference standards, such as: GB 9706.4 Medical electrical equipment Part 2-2: Special requirements for the safety of high-frequency surgical equipment. Ⅱ
9 0 1-03-04 high-frequency laparoscopic surgical instrument is a high-frequency electrode used to complete surgical operation under endoscope, which belongs to the application part of high-frequency surgical instrument; Under endoscopic surgery, enter the human body through endoscopic instrument channels or other instrument channels; It is used for routine cutting and coagulation of human tissues in endoscopic surgery. Ⅲ
10 0 1-03-04 needle electrode for radiofrequency ablation is usually used in conjunction with puncture needle and cannula, and belongs to the application part of radiofrequency ablation equipment. A temperature sensor is arranged on the ablation needle; The high frequency current generated by the RF generator is transmitted to the designated human tissue, so as to achieve the purpose of ablation/coagulation/necrosis; Used together with RF generator (RF controller) for human tissue ablation. Ⅲ
1101-03-05 The perfusion pump is generally composed of a host computer, a controller and a cable, which is used in conjunction with radio frequency ablation equipment to reduce the temperature of the contact part between the ablation area and the patient. Ⅱ
1201-08-01operation shadowless lamp The operation shadowless lamp consists of a fixed seat, a cross beam, a balance body, a balance elbow, a lamp holder elbow, a lamp holder, a dimming handle and a handle. According to the light source, structural type, technical parameters, configuration and additional functions, it can be divided into several models. Used for surgical lighting. The product performance index adopts the applicable parts of the following reference standards, such as YY 0627-2008 Medical electrical equipment Part 2: Special requirements for the safety of surgical shadowless lamps and diagnostic lighting lamps. Ⅱ
13 0 1-08-02 LED surgical lighting usually consists of light source and lamp holder. It can be used as auxiliary lighting for surgery, and can also be used for minor surgery alone. No shadowless effect. Divided into ceiling-mounted, wall-mounted or mobile. Ⅱ
14 0 1-08 disposable optical fiber products for spinal surgery lighting are composed of light source connector, optical fiber and head end. Provided in sterile form. After being connected with an illumination light source, it transmits light energy to the operation site to provide illumination for minimally invasive spinal surgery. Ⅱ
1501-09-01The power system of endoscopic surgery generally consists of a main machine, a handle and a planing cutter head. The motor drives the handle and cutter head to rotate mechanically, which is used to realize the surgical functions such as grinding or cutting tissues in endoscopic surgery (except nasal surgery). Apply or refer to the industry standard YY/T 0955 "Planer for Endoscopic Surgery Equipment". Ⅲ
1601-09-01The power system products for sinus surgery are generally composed of a main machine, a handle and a planer head, which are driven by a motor to rotate mechanically, and are used to achieve surgical functions such as cutting nasal tissues during sinus surgery. Apply or refer to the industry standard YY/T 0955 "Planer for Endoscopic Surgery Equipment". two
1701-10-04 surgical power supply system usually consists of main machine, control device, motor, handle and various knives. Used for cutting/cutting, grinding, drilling and other operations in open surgery. Ⅱ
1801-10-05 skin grafting netting machine is composed of netting base, hob assembly, locking assembly, aseptic slideway, etc. It is driven by external active instruments and used to expand skin grafts for burn treatment. Different specifications of slides can achieve different proportions of skin expansion.
Working principle:
The skin to be expanded is placed on a sterile glass slide, the glass slide is placed on a netting base, and then an external active instrument (motor) connected to the product is driven, so that the power of the motor is transmitted to the product, and the hob part of the final product can rotate to realize the rolling of the glass slide. Ⅱ
19 0 1- 10 preoperative skin preparation device generally consists of an electric handle host and a battery charger. Used in combination with disposable blades to remove hair from the patient's body and head before operation. Ⅱ
20 02-01-0/disposable surgical blade disposable surgical blade is made of carbon tool steel or alloy tool steel and other materials suitable for making blades, including the handle; 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. Ⅱ
2 1 02-03-03 disposable endoscopic ligature scissors are made of PVC, PPS and stainless steel. Which usually consists of a handle, a tube body and a cutter head/scissors receiving part; According to the different materials, design, technical parameters and applicable parts, it can be divided into several models and specifications. Can be provided in sterilized or non-sterilized form; Matching with endoscope, used for cutting ligature, etc. Ⅱ
22 02-04-09 The grasping forceps for endoscope can be composed of three-jaw pliers, a sheath and a control handle. The product is provided in a sterile state and can be used once. It is used for grasping and clamping tissues in endoscopic surgery. Ⅱ
23 02-04-09
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02-04- 13 tweezers for endoscope usually consist of a head, a rod or a flexible catheter and a handle, and the work of the head is transmitted and controlled by the operation of the handle. The universal head is made of stainless steel. It is operated under an endoscope during the operation, which is used to clamp, clamp, separate tissues, clamp foreign bodies and clamp instruments. The exemption does not include products with new materials, new mechanisms and new functions. Ⅱ
24 02-04- 10 The hose biopsy forceps for disposable endoscope are mainly composed of a forceps head, a spring outer tube and an operating handle, which can be divided into several models and specifications according to the different materials, designs and sizes. Provided in sterile form; Used for sampling living tissue under endoscope of digestive tract and respiratory tract. Or to clamp and remove foreign objects. The product performance index adopts the applicable parts of the following reference standards, such as YY/T 1076-2004 hose biopsy forceps for endoscope. Ⅱ
25 02-04- 12 foreign body forceps for endoscope The foreign body forceps for endoscope are made of stainless steel and plastic, and consist of a forceps head, a jacket, a connecting rod and a forceps handle. Clamp heads are divided into crocodile head, serrated head, wheat head, bead-taking head, new serrated head, cup head, pen container, inverted two-claw head, peanut head, three-claw head and so on. You can press. Can be provided in a sterilized or non-sterilized state; Can be combined with bronchoscope, esophagoscope, laryngoscope, etc. Can be used for tweezers to take out foreign bodies from trachea or upper digestive tract. Ⅱ
26 02-04- 13 The needle holder for endoscope bending is made of stainless steel, silica gel and resin, and consists of needle holding groove, push rod and control handle, which can be divided into several types according to the different materials, design and technical parameters. Can be provided in sterile form; Used for suture operation in abdominal endoscopic surgery. Ⅱ
27 02-04- 13 Application and clamping of endoscopic pliers This product can be composed of pliers head, pliers stem, turntable, pliers handle and other parts, usually made of stainless steel. Reusable. As a conveying device, the product is used to convey or remove ligating nails/clips through a sleeve with a specific size. Ⅱ
28 02-06-0 1 Disposable hemostatic clip is made of metal, high molecular polymer or other materials, which is used to temporarily clamp blood vessels or tissues during the operation, and is taken out immediately after the operation. Sterile and disposable. Ⅱ
29 02-06-0 1 Closure clip is used to mark, stop bleeding or close tubular tissue structure. There may be a conveyor belt. The product is equivalent to the product that has been approved for domestic registration, and the components and materials of the product are mature. Absorbable materials, new structural design, new mechanism of action, combined products of medicine and machinery are not included. Ⅲ
30 02-06 The product of minimally invasive fascia occluder includes two parts: closure fastener and suture guide. The closure fastener consists of a device body, a driver, a proximal wing, a bracelet and a window. The device body consists of a seat plate, a guide hole, an outlet, a finger grip and a control panel. The suture threading device consists of a needle and a handle. The product is sterilized and used once. It is used in laparoscopic surgery to gather tissues and perform percutaneous suture to close the surgical incision. Ⅱ
3 1 02-07-0 1 Medical suture needles are usually straight or arc-shaped, with circular, triangular or shovel-shaped tips and holes at the ends. Usually made of stainless steel. Used to suture tissue and skin. The product performance index adopts the applicable parts of the following reference standards, such as YY/T 0043 medical suture needle. Ⅱ
32 02-07-0 1 Disposable purse-string suture needle Disposable purse-string suture needle is made of metal and suture, and consists of two suture needles and a non-absorbent suture. The product is provided in aseptic form and is suitable for purse-string suture in digestive tract anastomosis. For product performance indicators, please refer to YY 0877 standard applicable part of purse-string suture needle. Ⅱ
Disposable sterile needle Disposable sterile needle is made of suitable stainless steel and consists of a flat handle and a triangular needle tip. Puncture the skin when testing the skin's immediate allergic reaction, so that the antigen solution on the skin can penetrate into the skin for use. Does not include needles containing antigen liquid. Ⅱ
34 02-07-02 disposable endoscopic pneumoperitoneum puncture trocar is made of suitable polymer materials such as ABS, and consists of an outer sleeve and a puncture inner core that can be locked together; Can be divided into several models and specifications according to the different materials, patterns and sizes; It is a surgical instrument for endoscope, which is punctured and fixed on the abdominal wall to form the gas injection channel of pneumoperitoneum and the working channel of laparoscopy or other surgical instruments. Ⅱ
The skin puncture box is made of polymethylmethacrylate polymer. It consists of a test head and a disk. Testing tools for allergens in allergic people. Ⅱ
The pneumoperitoneum needle consists of a needle tube, a handle, a piston, a locking joint and a core needle. , excluding Class III medical device parts. Used to establish pneumoperitoneum in abdominal endoscopic surgery. The basic principle, scope of application, performance and composition structure are the same as those of the listed products. Exemption does not include the use of new materials, polymers, drugs, biological products and other products with special coatings, as well as products with special structure, function and scope of application. Ⅱ
37 02-07-03 The performance, structure, composition and use of disposable breast positioning wire and its guide pin belong to YY/T 0880, which can be completely covered by disposable breast positioning wire and its guide pin. The needle tube of the guide needle shall be made of the material in GB 18457, and the positioning wire shall be made of stainless steel or other alloy materials. Clinical use of this product in order to facilitate the surgical removal of local small breast lesions, under X-ray or ultrasound, the breast positioning wire and its guidance are used to locate the lesions, giving clear guidance to clinical surgeons, thus narrowing the incision and reducing surgical injuries. Exemption does not include the use of new materials, active ingredients, new technologies, new designs or products with new mechanisms and functions. Ⅱ
38 02-07-04 Disposable endoscopic ultrasound aspiration biopsy needle usually consists of head, rod or flexible catheter and handle. The head is needle-shaped, and the work of the head is transmitted and controlled by the operation of the handle. The universal head is made of stainless steel. Sterile supply. Exemption does not include products with new materials, new mechanisms of action and new functions, as well as products used for injection, positioning and treatment. Ⅱ
39 02-08-02 Tissue Hook for Endoscope The tissue hook for endoscope is made of stainless steel and aluminum, and consists of working end (pull rod), instrument rod, grip, etc. According to different materials, designs and technical parameters, it can be divided into several models. Provided in sterile form; Used for temporary traction of tissues in various endoscopic operations. Ⅱ
40 02-09-02 Endoscopic curette This product can be composed of a tip part, an insertion part, a handle and other parts. The product is provided in sterile form and is disposable. This product is inserted into the body cavity through an endoscope, and is used to collect tissues or cells in the body cavity through the advance and retreat operation of the product and the bending operation of the curette tip. Ⅱ
4 1 02-09 disposable skin curette consists of curette head and handle, and may have a protective cap. The curette head is made of stainless steel or other non-toxic metal materials, and the handle and protective cap are made of plastic materials; Can be divided into various specifications according to the inner diameter of the curette head and the shape of the handle; The product is sterilized and used once; It is suitable for scraping necrotic tissue and dander in surgical operation. Ⅱ
42 02- 1 1-03 disposable urethral dilator A disposable urethral dilator consists of a head, a stem and a handle, and can be made of suitable plastic. According to different materials, designs and technical parameters, it can be divided into several models and specifications. Provided in sterile form; Used to dilate urethra when urethral stricture occurs. Ⅱ
43 02- 1 1-03 non-vascular lumen guide wire-non-vascular lumen guide wire for urinary tract-urinary tract guide wire consists of guide wire and push tube. Guide wires have different materials and shapes, such as metal guide wire, metal elbow guide wire, PE guide wire, PTFE guide wire, PTFE coated guide wire, PTFE coated elbow guide wire and so on. The guide wire can be coated with hydrophilic/hydrophobic coating; According to the product material, design, technical parameters and expected use, it can be divided into several models and specifications. Provided in sterile form; Endoscope is supported and guided by J-shaped catheter and minimally invasive dilation and drainage kit. Ⅱ
44 02- 1 1-03 dilator for esophageal and cardiac stenosis The dilator for esophageal and cardiac stenosis consists of an expansion strip (marked by X-ray development), a guide wire and a safety soft spring. The expansion strip is made of soft PVC plastic, and the guide wire is made of nickel-titanium alloy, which can be divided into several models and specifications according to different materials, designs, diameters/lengths, etc. Can be provided in sterilized/unsterilized form; It can be used to treat esophageal and cardiac stenosis and dilatation under endoscope. Ⅱ
45 02- 1 1-03 disposable urethral dilator consists of catheter, connector and guide wire, which can be divided into several models and specifications according to materials, design, pipe diameter/length, etc. , and can be combined into a set by one or more; Provided in sterile form; It is suitable for dilating urethral stricture and relieving urethral obstruction in urology. Ⅱ
46 02- 1 1 The product of the expander for the external cavity of the endoscope can be composed of a tube body, an expansion bag, a tube seat, a sealing ring, a three-way one-way gas injection valve (seat), an introduction column, a stop clip and a protective cap. Before laparoscopic minimally invasive surgery, a surgical space was established between the peritoneal cavity and the surgical site. Ⅱ
47 02- 12-0 1 disposable puncture needle for laparoscopy can be made of suitable metal materials and polymer materials, and its typical structure can include puncture needle, puncture sleeve, gas injection valve, throttle valve and sealing cap; Can be divided into several models and specifications according to different materials, design and technical parameters; Products are provided in aseptic form; It is used to puncture human abdominal wall tissue during laparoscopic examination and operation, and to establish a working channel for abdominal surgery. The product performance index adopts the applicable parts of the following reference standards, such as YY 0672. 1-2008 Endoscopic Instruments, Part 1: Laparoscopic Puncture. Ⅱ
48 02- 12-0 1 laparoscopic puncture This product can generally consist of puncture sleeve and puncture core. The product is sterilized and used once. It is used in conjunction with endoscope to puncture human tissue and establish abdominal cavity channel during endoscopic surgery. Exemption does not include: using new materials; Use non-DEHP plasticizer; Products containing functional polymers, drugs, biological products and other special coatings include active ingredients, new technologies, new designs or products with new mechanism of action, as well as products with special structure, function and application scope. Ⅱ
49 02- 12-02 disposable skin tissue drill consists of a trephine and a handle, and may have a protective cap. Sterile disposable; Suitable for drilling skin tissue. Ⅱ
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