[product name] disposable oral bag。
Type I (check type)。
[name of registrant] henan jianqi medical equipment co. LTD.
The dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
[after-sales service unit] henan jianqi medical equipment sales co., LTD.
[name of production enterprise] henan jianqi medical equipment co., LTD.
The dingluan industrial zone in changyuan county。
[production address] dingluan industrial zone, changyuan county。
[contact information] 0373-8690789.
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.
[registration certificate no。] yu ordnance mark 20142660134。
[technical requirements no。]
[structure and composition] the product consists of basic configuration and selection configuration; Basic configuration: dental probe, tray; Choose configuration: medical forceps, medical cotton ball, medical absorbent gauze piece, mouth mirror, aprons, disposable medical rubber examination gloves, disposable towels, disposable towels, medical cotton, medical nonwovens dressings, disposable medical cloth, tissue paper, hemostatic forceps, a spatula, small bowl, straw.
[product performance] 1. The configuration of the oral package and the name, specification and quantity of the products shall meet the requirements of table 1 in the product technical requirements. 2. The oral packaging should be well sealed, with no gaps and no holes; No damage, no stain or impurities should be found in the parts of the oral cavity. Folded parts should be folded neatly. 3. The surface of the dental probe shall be free of pores, cracks, abrasion marks, peeling residues, acid traces, oil stains and polishing and polishing residues; Satin finish should be uniform and smooth, and can reduce the reflection effect. If the tooth probe has a mirror surface, it should have no defects and abrasion marks, and should have a good reflective surface; The hardness of working tip should not be less than 480HV1; The minimum tensile strength of the working tip should be 1700MN/mm2; Should be free from corrosion; In addition to the serrated martensitic stainless steel shank, any defect is considered to be evidence of corrosion of the instrument; The physical appearance of the heat-resistant device should be unchanged; Device connection should not be loosened; Device connection should not be loosened; The total length should be less than or equal to 178mm. 4. The medical tweezers should be symmetrical, and the appearance should be smooth, without front edge, burr, crack, pitting and trachoma. Tweezers should have good elasticity; The two pieces of tweezers should be strong enough to withstand the tension of 15N without breaking. The teeth should be clear and complete, should not be missing teeth, bad teeth defects; The guiding pin and positioning pin of tweezers should be firmly fixed. When the tweezers are open and closed, they should be flexible and should not be jammed. The handle of the tweezers should be clear and complete. There should be no flowers or flowers. 5. The appearance should be free of stains, mildew and no damage; The thickness of the apron should not be less than 0.01mm and the gram weight should not be less than 20g/m2. 6. The medical cotton ball shall be a qualified product for obtaining the medical device registration certificate. 7. The pallet appearance should be smooth, without burr and injection flow; Thickness shall not be less than 0.1mm. 8. The mirror should have bubbles, ripples, sand grains, pitting, scratches, lines and stains. Mirror shape should be the rule, mirror edge should be free of damage, debris occurrence; The mirror should reflect well and should be able to bear its own weight. The handle should be free of frills, burrs, stains, cracks and obvious bending; The handle should be clearly visible on the handle. 9. Oral bags should be sterile. 10. Oral package is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not be greater than 10ug/g.
[scope of application] clinical oral examination and treatment.
Contraindication: no absolute contraindication。
1. This product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.
2。 See packaging seal or label on the production batch number, and the sterilization date is in the outer packing box。
3。 This product is sterilized by ethylene oxide。
[use method] 1。 Select the applicable patient's specifications and model, and then open the package after the outer packing is in good condition。
2。 Take out the accessories according to the surgical needs。
3. After the product is finished, it should be treated with medical waste to avoid pollution.
[storage method] 1. This product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.
2。 Handle gently in handling and avoid violent collision;
3. The product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.
[production date] see packaging seal or label。
Expiry date: see packaging seal or label.
[label, package logo]
[specification preparation date] August 24, 2017.