1.1 This product is composed of a needle tube, a needle holder and a sheath. It is used together with a dental irrigator for clinical dental and oral use. This product complies with the standard requirements of ISO/T 0587-2018 "Disposable dental needle".
1.2 Product structure and composition
Note: This figure is only a description of the structure of the product, not the only form specified by the standard.
Figure 1 sterile dental needle
1.3. Product specifications
The appearance structure is consistent with ISO/T 0587:2018, and the specifications are divided into the following types according to the outer diameter and opening mode of the steel needle:
30G*8mm,30G*11mm,30G*21mm,30G*25mm,30G*30mm,27G*12mm,27G"21mm,27G*25mm,27G*30mm,27G*35mm,27G*38mm,27G*40mm
2, product packaging and classification
2.1. Product packaging
The raw material of Disposable dental needle is polyacrylic resin (PP plastic) \ stainless steel needle tube SUS304 for manufacturing medical devices. The plastic tube is sealed in single packaging, the middle packaging is cardboard box or plastic bag packaging, and the outer packaging is double-layer corrugated carton packaging.
2.2. Product classification
The product is a sterile, passive, used surgical invasive medical device, according to the provisions of MDD93/42/EEC Appendix IX Rule 6, this product belongs to Class Ⅱa medical device.
3. List of qualified suppliers
Id. NO | Name of goods supplied Product name | Supplier name Supplier name |
1 | Medium box. Label. Instruction manual | Jining Happy Printing Co., LTD |
2 | Big BOX | Heze Xinya Paper Products Co. LTD |
3 | Polypropylene | Beijing Zhouhuang Trading Co., LTD |
4 | Color master, color powder | Kunshan Shixin Plastic color master Co., LTD |
5 | 141B | Zibo Luxuan Industry and Trade Co., LTD |
6 | Saio silicone oil | Weihai Huakang Biomaterial Technology Co., LTD |
7 | glue | Taizhou Huangyan Yongbo Adhesive Factory |
4.List of raw materials
Accessory names | Raw Materials |
Piercing end protector | Polypropylene |
Butt end protective cover | Polypropylene |
Needle holder | Polypropylene |
Needle tubing | SUS304 stainless steel |