Office of the food and Drug Administration on 172 products s
All provinces, autonomous regions and municipalities directly under the food and Drug Administration:
To meet the needs of supervision and administration of medical devices, Office Organization relevant units and experts on 172 products such as artificial blood vessel ring management defines the category. Are hereby notified as follows:
One, as a class III medical device management products (5)
(A) the artificial blood vessel ring: made with titanium alloy materials. Artificial vessel implantation surgery, aided by artificial blood vessel and blood vessels of the human body connection. Use of artificial blood vessels and vascular products outside, from outside the blood vessels ligation of nylon tie vascular product overlaps, forming non-stitched artificial blood vessels and vascular connections. After the operation, the product will be retained in the body for a long time. Classification code: 6846.
(B) sodium alginate gel: Natural sodium carboxymethyl cellulose, sodium alginate, water. For once, and second degree burn wound to absorb wound exudate, clearing the necrosis rotting tissue and use gel physical sealing stop wound bleeding. Classification code: 6864.
(C) the seaweed polysaccharide gel from seaweed polysaccharides, sodium carboxymethyl cellulose, water. Acute and chronic skin wounds, wound, physical barrier absorbs exudate, providing micro-environment for wound healing. Classification code: 6864.
(D) the alginate fill: alginate (not silver) fiber bar dressing. For ear, nasal cavity, colorectal surgery, skin ulcers or puncture, drain and stoma with cavity caused by wounds, wounds of trauma soft tissue defects, fill the wound after the physical barrier and absorbing exudate, providing micro-environment for wound healing. Classification code: 6864.
(E) the bronchial balloon catheter hemostasis: composed by balloon catheter, joints. For the treatment of bronchial arterial bleeding. When using balloon catheters into bleeding along the nasal cavity bronchial areas, use saline filled balloon, oppressing bronchial wall, site of extrusion of bronchial blood vessels, achieve hemostasis purpose. Classification code: 6866.
Second, as a class II medical device management products (24)
(A) disposable surgical use surface pads: made from stainless steel mesh and medical grade silicone rubber. By applying external force, stainless steel mesh can be bent into shape. Provided sterile. For open abdominal surgery patients in isolated organs, and laparoscopic surgery, gathering, protecting organs and avoid organ stop during surgery. No anti-adhesion effects. Classification code: 6801.
(B) medical skin markers (including ink): by the coil core-spun polyester fiber, ink, pen, pen, pen, end caps and Rod composition, in which ink is composed of water, alcohol, ethylene glycol, composed of gentian and sodium benzoate. Used in surgery, radiation therapy, and skin treatment in the patient's skin (mucous membranes and skin breakage-free) marking and positioning. Classification code: 6801.
(C) small vessels measuring tape: to a point of caliper, caliper marked on the scale. Made of stainless steel material. Non sterile provided, which can be reused. For microsurgery, measure the outside diameter of the small blood vessels. Classification code: 6802.
(four) brain plane positioning ruler is composed of coronal, sagittal and Nakama Itami. The use of sterile disposable products. Used for measuring and locating plane Department of cerebral surgery surgery. Classification encoding: 6803.
(five) transcatheter implantable artificial heart valve device consists of a handle and a preset base two parts, base with bracket, bracket for placing holes to be compressed by transcatheter implantable artificial heart valve. Provide sterile. For transcatheter implantable artificial heart valve implantation surgery, transcatheter heart valve in vitro compression, the installation to complete delivery system. Classification encoding: 6807.
(six) biliary drainage: needle comprises a needle, needle tube, connector. Made of stainless steel. Reusable. The use of needle insertion in the bile duct, connecting head connected with the active suction equipment, realize the drainage of bile. For minimally invasive surgery, as the bile drainage channel. Classification encoding: 6808.
(seven) knot pushing device for abdominal surgery: composed of knot pusher tube, knot pusher handle. Made of stainless steel. Non sterile, reusable. For abdominal minimally invasive surgery on pathology of knotting in laparoscopic assisted. Classification encoding: 6808.
(8) biopsy gun: from the gun body cover, a front cover, back cover, a gun body, slider, slider, after firing switch, before firing switch, insurance button, a main spring, handle composition. With the use of needle biopsy, exerts a force, firing biopsy needle, from the liver, kidney, prostate, breast, spleen, lymph nodes and a variety of soft tissue tumor tissues to obtain specimens for biopsy. Classification code: 6815.
(9) fat transplantation set: is composed of a bottle stopper puncture device, an inner tooth pipe joints, silicone tube, outer tooth pipe connecting head, a spring, a four-way, non-return duckbill valve, plug, liposuction needle. For plastic surgery of autologous fat transplantation, the use of a compression spring to generate negative pressure liposuction, grease, water injection, so as to achieve the purpose of the transfer of fatty. Classification code: 6816.
(ten) the disposable erectile strength measurement by fixed belt, the pressure belt, adhesive joint. Non sterile, disposable. The pressure belt is divided into red, yellow and blue three. Based on the physiological penis anatomy and mechanics of the foundation design, different degree of penile erection can break the corresponding pressure belt. For men with erectile dysfunction screening, psychological impotence and organic impotence in the differential diagnosis, psychological impotence, impotence and adjuvant therapy in the treatment process, to observe the curative effect of visual stimulation under the hardness of the penis aided detection. Classification encoding: 6820.
(eleven) endoscopic Guide: the head end, a guide tube, connector and handle. Non sterile, reusable. First use the product through the handle is inserted in the nasal cavity, nasal or nasal endoscopic catheter will be fixed in the internal product, promote the product will handle the nasal catheter or nasal endoscopic nasal cavity to transport products. Classification encoding: 6822.
(twelve) joint rehabilitation training device, which is composed of the main components, sets, and manual button bandage treatment. Passive product. Through the main component, and impaired limb bandage patients, treatment of impaired limb rotation angle button. On the shoulder, elbow, forearm and finger joints, wrist joints, knee, ankle and toe joint rehabilitation training, the activity of partially or fully open limited joint. Adjunctive treatment for fracture and joint surgery. Classification encoding: 6826.
(thirteen) the carpal tunnel paste: made of polyester material, medical glue. The use of physical paste fixation, lift the pressure on the palms of the hands of the median nerve in the skin to relieve the nerve under stress, relieve the patients with carpal tunnel syndrome paralysis, wrist pain, finger grip and arm movement inconvenience and other symptoms. Classification encoding: 6826.
(fourteen) pelvic orthosis composed of pelvic and hip knee ankle foot orthosis. By improving the activity of the hip (adduction, abduction, external rotation, Qu Shen), the pelvis gradually returned to normal position. For corrective training on patients with pelvic deformity, hip dysplasia and subluxation of hip after operation. Classification encoding: 6826.
(fifteen) onychocryptosis correction hook: by elastic bands (made of medical silicone rubber) and two correction (stainless steel) hook, the elastic belt is connected with two correction hook. When using the two hooks are respectively hooked with toe nail correction on both sides of the edge, pull on the correction hook through the elastic belt, to prevent nail muscle growth. For the treatment of onychocryptosis or correction. Classification encoding: 6826.
(sixteen) peritoneal dialysis pipe: mainly composed of a tube body, an elastic cap, Liquor Dialysisintraperitoneus joint, peritoneal dialysis tube fittings, lock fitting and protective cap. Provide sterile. For patients with peritoneal dialysis, peritoneal dialysis catheter and Liquor Dialysisintraperitoneus connection pipeline, through the pipeline can be poured into the new dialysate to the patient, can also be used for drainage for patients with intra-abdominal fluid into the drainage bag. Classification encoding: 6845.
(seventeen) bone grinding consists of the grinding head and the grinding chamber. In the process of bone surgery for the Department of Stomatology, grinding into powder, the powder is used in operation. Classification encoding: 6855.
(eighteen) the external maxillary traction device by mandibular traction device, combined with traction device, high traction device, neck strap, maxillary protraction, extraoral arch and J shaped hook. For orthodontic treatment, worn on the jaw of non normal growth and development in estuary, traction force generated by the auxiliary products, correction of jaw deformity. Classification encoding: 6855.
(19) skin scar reduction device: made from medical stainless steel chain buckle, medical adhesive tape, medical color tape, antiskid fixing bands. Use symmetrically pasted in scars on both sides of the normal skin, pinch scars on both sides of the skin, reduce the scar of tension to prevent scar hyperplasia, used as an aid to improve the pathological scar of skin, help prevent skin pathological scar formation, not for nonhealing wounds. Classification code: 6864.
(20) medical infusion posted: made by the substrate layer, medical hot melt pressure-sensitive adhesive layer, absorbent pad, release paper composition, substrate layer by non-woven fabric or polyethylene material. Sterile supply, disposable. For transfusion and blood transfusion, the transfusion needle is used for protecting the needle and the needle of the transfusion needle. Classification code: 6864.
(twenty-one) the medical developing gauze piece: the main body is the medical absorbent cotton gauze, the gauze is mixed with the X light to detect the barium wire (film). Sterile supply. Used as a surgical dressing, with X - ray detection function. Classification code: 6864.
(twenty-two): disposable negative pressure drainage device composed of a body, a spring, a connecting pipe, connector, regulator, including manual negative pressure source (negative pressure ball), not including the drainage catheter is inserted into the body. For clinical negative pressure drainage, connected with the drainage catheter is inserted into the body, collect drainage. Classification encoding: 6866.
(twenty-three) the balloon pressure device is composed of an air charging device, a pressure gauge, a connecting pipe and a joint. In cardiac interventional procedures, the balloon is used to connect with the balloon dilatation catheter, and the pressure value of the pressure gauge on the instrument is used to accurately fill and contract the balloon to achieve the purpose of expanding or contracting the balloon. Classification code: 6866.
(24) a one-time use of sterile gastroschisis treatment bag: products from the flange of the jacket tube, a liquid pumping pipe, positioning clamp, hoists climbing, valves, valve outer sleeve. Provide sterile. For the adjuvant treatment of neonatal congenital abdominal wall defects. When the children exposed to bowel, organ gently squeezed into the product bag, then the product into the flange end fixed on the inner wall of the product and gastrochisis bag suspension, which gradually all returning into the peritoneal cavity by bag bowel and viscera gravity, after taking out the product, with suture of abdominal wall defect at. Human contact time is not more than 10 days. Classification encoding: 6866.