[Production License Number] Sujiang Medical Device Production License No. 20240191

【Medical Device Registration Certificate Number】 National Medical Device Registration No. 20253142418

[Product Technical Requirements Number] National Medical Device Registration No. 20253142418

【Model Specifications】

Five needles: 0.23; nine needles: 0.23

【Structural Composition】

Single-use sterile injection needles are available in two models—five-needle and nine-needle—depending on the number of needle barrels. The five-needle model consists of a negative-pressure aspiration port, housing, needle hub, adjustment knob, needle barrel, and fluid-delivery connector; the nine-needle model comprises a negative-pressure aspiration port, protective cap, housing, needle hub, adjustment knob, needle barrel, and fluid-delivery connector. The needle barrels are made of 06Cr19Ni10 austenitic stainless steel, while the adjustment knob, needle hub, housing, and negative-pressure aspiration port are made of polypropylene, and the fluid-delivery connector and protective cap are made of polycarbonate. The product is supplied in a sterile condition, sterilized by ethylene oxide, and intended for single use only.

【Main Technical Parameters】

The syringe barrel shall be clean and free of foreign matter, and the barrel shall be straight; the injection needle and barrel shall be able to be simultaneously exposed in a single operation. The adjustment knob shall be rotatable to adjust the length of the needle and barrel: rotating counterclockwise increases the exposed length, while rotating clockwise decreases it. The injection needle shall be sterilized by ethylene oxide; after sterilization and subsequent degassing, the residual ethylene oxide level shall be ≤10 µg/g; bacterial endotoxins shall be less than 20 EU per unit; and the product shall be sterile after ethylene oxide sterilization.

The needle protrusion length of the syringe barrel shall be ≤3 mm, and the limit deviation for the needle protrusion length of a single syringe barrel shall be ±0.3 mm.

【Scope of Application】

To be used in conjunction with single-use sterile syringes and electronic injectors for the intradermal injection of sodium hyaluronate. Must be administered only by qualified healthcare professionals and is intended for use exclusively in medical institutions.

[Installation and Usage Instructions or Diagrams]

1. Select products of appropriate specifications and models based on clinical needs;

2. Before use, first check that the packaging is intact and that the sterilization date and expiration date are within the valid period;

3. After confirming that the packaging and product expiration date are in good condition, open the package at the sealed opening of the individual pack and remove the product.

4. After disinfecting the skin at the injection site, perform the procedure in accordance with clinical aseptic techniques and relevant operational protocols.

5. Adjust the injection needle length adjustment knob according to clinical needs to select the appropriate needle length.

 

Single-use sterile injection needles are available in two models—five-needle and nine-needle—depending on the number of needle barrels. The five-needle model consists of a negative-pressure aspiration port, housing, needle holder, adjustment knob, needle barrel, and fluid-delivery connector; the nine-needle model comprises a negative-pressure aspiration port, protective cap, housing, needle holder, adjustment knob, needle barrel, and fluid-delivery connector. The needle barrels are made of 06Cr19Ni10 austenitic stainless steel, while the adjustment knob, needle holder, housing, and negative-pressure aspiration port are made of polypropylene, and the fluid-delivery connector and protective cap are made of polycarbonate. The product is supplied in a sterile condition, sterilized by ethylene oxide, and intended for single use only.