[Production License Number] Sujiang Medical Device Production License No. 20240191
[Product Registration Certificate Number] National Medical Device Registration No. 20253142330
[Product Technical Requirements Number] National Medical Device Registration No. 20253142330
【Specifications and Model】
Table 1: Specification and Model Table
| Serial Number |
Model Specifications |
Serial Number |
Model Specifications |
| 1 |
DMRW 1.2×70 PPRW 1.2×30 |
30 |
DMTW 1.2×70 PPTW 1.2×30 |
| 2 |
DMRW 1.2×50 PPRW 1.2×30 |
31 |
DMTW 1.2×50 PPTW 1.2×30 |
| 3 |
DMRW 1.1×70 PPRW 1.2×30 |
32 |
DMTW 1.1×70 PPTW 1.2×30 |
| 4 |
DMRW 0.8×70 PPRW 0.9×38 |
33 |
DMTW 0.8×70 PPTW 0.9×38 |
| 5 |
DMRW 0.8×70 PPRW 0.8×35 |
34 |
DMTW 0.8×70 PPTW 0.8×35 |
| 6 |
DMRW 0.8×50 PPRW 0.9×38 |
35 |
DMTW 0.8×50 PPTW 0.9×38 |
| 7 |
DMRW 0.8×50 PPRW 0.8×35 |
36 |
DMTW 0.8×50 PPTW 0.8×35 |
| 8 |
DMRW 0.7×70 PPRW 0.8×35 |
37 |
DMTW 0.7×70 PPTW 0.8×35 |
| 9 |
DMRW 0.7×70 PPRW 0.7×30 |
38 |
DMTW 0.7×70 PPTW 0.7×30 |
| 10 |
DMRW 0.7×50 PPRW 0.8×35 |
39 |
DMTW 0.7×50 PPTW 0.8×35 |
| 11 |
DMRW 0.7×50 PPRW 0.7×30 |
40 |
DMTW 0.7×50 PPTW 0.7×30 |
| 12 |
DMRW 0.7×40 PPRW 0.8×35 |
41 |
DMTW 0.7×40 PPTW 0.8×35 |
| 13 |
DMRW 0.7×40 PPRW 0.7×30 |
42 |
DMTW 0.7×40 PPTW 0.7×30 |
| 14 |
DMRW 0.6×70 PPRW 0.7×30 |
43 |
DMTW 0.6×70 PPTW 0.7×30 |
| 15 |
DMRW 0.6×70 PPRW 0.6×25 |
44 |
DMTW 0.6×70 PPTW 0.6×25 |
| 16 |
DMRW 0.6×50 PPRW 0.7×30 |
45 |
DMTW 0.6×50 PPTW 0.7×30 |
| 17 |
DMRW 0.6×50 PPRW 0.6×25 |
46 |
DMTW 0.6×50 PPTW 0.6×25 |
| 18 |
DMRW 0.5×70 PPRW 0.6×25 |
47 |
DMTW 0.5×70 PPTW 0.6×25 |
| 19 |
DMRW 0.5×70 PPRW 0.5×20 |
48 |
DMTW 0.5×70 PPTW 0.5×20 |
| 20 |
DMRW 0.5×50 PPRW 0.6×25 |
49 |
DMTW 0.5×50 PPTW 0.6×25 |
| 21 |
DMRW 0.5×50 PPRW 0.5×20 |
50 |
DMTW 0.5×50 PPTW 0.5×20 |
| 22 |
DMRW 0.5×40 PPRW 0.6×25 |
51 |
DMTW 0.5×40 PPTW 0.6×25 |
| 23 |
DMRW 0.5×40 PPRW 0.5×20 |
52 |
DMTW 0.5×40 PPTW 0.5×20 |
| 24 |
DMRW 0.4×50 PPRW 0.5×20 |
53 |
DMTW 0.4×50 PPTW 0.5×20 |
| 25 |
DMRW 0.4×50 PPRW 0.4×13 |
54 |
DMTW 0.4×50 PPTW 0.4×13 |
| 26 |
DMRW 0.4×40 PPRW 0.5×20 |
55 |
DMTW 0.4×40 PPTW 0.5×20 |
| 27 |
DMRW 0.3×40 PPRW 0.4×13 |
56 |
DMTW 0.3×40 PPTW 0.4×13 |
| 28 |
DMRW 0.3×25 PPRW 0.4×13 |
57 |
DMTW 0.3×25 PPTW 0.4×13 |
| 29 |
DMRW 0.3×25 PPRW 0.3×13 |
58 |
DMTW 0.3×25 PPTW 0.3×13 |
【Structural Composition】
The single-use blunt-tip injection needle and accessories consist of a blunt-tip injection needle and a skin-penetrating needle. Each needle comprises a needle barrel (made of 06Cr19Ni10 stainless steel), a needle hub (made of polypropylene), and a protective sheath (made of polypropylene). This product is supplied in a sterile condition, sterilized by ethylene oxide, and intended for single use only.
1 needle hub; 2 needle barrel; 3 protective sheath; 4 scale markings
Figure A1 Schematic diagram of the blunt-end injection needle structure
Figure A2 Schematic diagram of the blunt-tip injection needle tip
1 needle holder; 2 needle tube; 3 protective cover
Figure A3 Schematic diagram of the skin-piercing needle structure
【Product Performance】
1) Ethylene oxide residue: ≤10 μg/g.
2) Sterility: Should be sterile.
3) Bacterial endotoxins: <20 EU per vial.
4) The connection strength between the needle hub and the needle tube shall comply with the requirements specified in Table 2.
Table 2: Fastening Strength Values for Connector Pin and Tube Connections
| Specification, mm |
Tensile force: N |
Specification, mm |
Tensile force: N |
| 0.3 |
22 |
0.7 |
40 |
| 0.4 |
22 |
0.8 |
44 |
| 0.5 |
22 |
1.1 |
69 |
| 0.6 |
34 |
1.2 |
69 |
5) The maximum puncture force of the needle tip of the skin-penetrating needle shall comply with the requirements specified in Table 3.
Table 3 Puncture Force
| Specification, mm |
Puncture force, N |
Specification, mm |
Puncture force, N |
| 0.3–0.6 |
≤0.70 |
0.7 to 0.9 |
≤0.85 |
| 1.2 |
≤1.15 |
【Scope of Application】
This product is indicated for intradermal injection of modified sodium hyaluronate gel for facial volumization. It is intended for use only by qualified healthcare professionals in a clinical setting.
【Instructions for Use】
1) Select the appropriate model and specification according to the injection site location, area, and dosage as specified in Appendix Table 1.
2) Check that the packaging is intact and that the product is within its expiration date.
3) Open the small package along the tear notch, remove the product, and inspect all components for damage.
4) Disinfect the skin at the injection site.
5) Hold the skin-piercing needle with the bevel of the needle tip facing upward, maintaining an angle of 30–45° relative to the skin. Pierce the skin, advance the needle to the predetermined depth, then withdraw it to create an injection site.
6) Connect the blunt-ended injection needle to a syringe pre-filled with injectable sodium hyaluronate. Using the needle hub marker that indicates the orientation of the side holes on the blunt-ended needle, align the syringe plunger with the needle-length scale to determine the injection depth. Insert the needle perpendicularly or at an angle of at least 45° relative to the skin surface, advancing it through the injection site to the predetermined depth within the dermis, then withdraw the needle in a fan-shaped, multi-point pattern or in a linear fashion while simultaneously injecting the drug.
7) After the injection is complete, withdraw the needle and gently massage the injection site to ensure smooth integration with the surrounding tissues.
Appendix 1: Injection Site and Recommended Model Specifications
| Injection site |
Model Specifications |
| forehead |
DMRW 0.8×70 PPRW 0.9×38, DMRW 0.8×70 PPRW 0.8×35, DMRW 0.8×50 PPRW 0.9×38, DMRW 0.8×50 PPRW 0.8×35 |
| DMTW 0.8×70 PPTW 0.9×38, DMTW 0.8×70 PPTW 0.8×35, DMTW 0.8×50 PPTW 0.9×38, DMTW 0.8×50 PPTW 0.8×35 |
|
| DMRW 0.7×70 PPRW 0.8×35, DMRW 0.7×70 PPRW 0.7×30, DMRW 0.7×50 PPRW 0.8×35, DMRW 0.7×50 PPRW 0.7×30, DMRW 0.7×40 PPRW 0.8×35, DMRW 0.7×40 PPRW 0.7×30 |
|
| DMTW 0.7×70 PPTW 0.8×35, DMTW 0.7×70 PPTW 0.7×30, DMTW 0.7×50 PPTW 0.8×35, DMTW 0.7×50 PPTW 0.7×30, DMTW 0.7×40 PPTW 0.8×35, DMTW 0.7×40 PPTW 0.7×30 |
|
| DMRW 0.6×70 PPRW 0.7×30, DMRW 0.6×70 PPRW 0.6×25, DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
|
| DMTW 0.6×70 PPTW 0.7×30, DMTW 0.6×70 PPTW 0.6×25, DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| Brow area |
DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
| DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
|
| DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| Eyebrow |
DMRW 0.6×70 PPRW 0.7×30, DMRW 0.6×70 PPRW 0.6×25, DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
| DMTW 0.6×70 PPTW 0.7×30, DMTW 0.6×70 PPTW 0.6×25, DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| DMRW 0.5×70 PPRW 0.6×25, DMRW 0.5×70 PPRW 0.5×20, DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
|
| DMTW 0.5×70 PPTW 0.6×25, DMTW 0.5×70 PPTW 0.5×20, DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
|
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| Temporal |
DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
| DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
|
| DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
|
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| Upper eyelid |
DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| DMRW 0.3×40 PPRW 0.4×13, DMRW 0.3×25 PPRW 0.4×13, DMRW 0.3×25 PPRW 0.3×13 |
|
| DMTW 0.3×40 PPTW 0.4×13, DMTW 0.3×25 PPTW 0.4×13, DMTW 0.3×25 PPTW 0.3×13 |
|
| tear trough |
DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
| DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
|
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| infraorbital |
DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
| DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
|
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| nose |
DMRW 0.6×70 PPRW 0.7×30, DMRW 0.6×70 PPRW 0.6×25, DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
| DMTW 0.6×70 PPTW 0.7×30, DMTW 0.6×70 PPTW 0.6×25, DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| DMRW 0.5×70 PPRW 0.6×25, DMRW 0.5×70 PPRW 0.5×20, DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
|
| DMTW 0.5×70 PPTW 0.6×25, DMTW 0.5×70 PPTW 0.5×20, DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
|
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| Midface |
DMRW 0.6×70 PPRW 0.7×30, DMRW 0.6×70 PPRW 0.6×25, DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
| DMTW 0.6×70 PPTW 0.7×30, DMTW 0.6×70 PPTW 0.6×25, DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| DMRW 0.5×70 PPRW 0.6×25, DMRW 0.5×70 PPRW 0.5×20, DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
|
| DMTW 0.5×70 PPTW 0.6×25, DMTW 0.5×70 PPTW 0.5×20, DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| Nasolabial fold |
DMRW 0.5×50 PPRW 0.6×25, DMRW 0.5×50 PPRW 0.5×20, DMRW 0.5×40 PPRW 0.6×25, DMRW 0.5×40 PPRW 0.5×20 |
| DMTW 0.5×50 PPTW 0.6×25, DMTW 0.5×50 PPTW 0.5×20, DMTW 0.5×40 PPTW 0.6×25, DMTW 0.5×40 PPTW 0.5×20 |
|
| DMRW 0.4×50 PPRW 0.5×20, DMRW 0.4×50 PPRW 0.4×13, DMRW 0.4×40 PPRW 0.5×20 |
|
| DMTW 0.4×50 PPTW 0.5×20, DMTW 0.4×50 PPTW 0.4×13, DMTW 0.4×40 PPTW 0.5×20 |
|
| Mandibular region |
DMRW 0.8×70 PPRW 0.9×38, DMRW 0.8×70 PPRW 0.8×35, DMRW 0.8×50 PPRW 0.9×38, DMRW 0.8×50 PPRW 0.8×35 |
| DMTW 0.8×70 PPTW 0.9×38, DMTW 0.8×70 PPTW 0.8×35, DMTW 0.8×50 PPTW 0.9×38, DMTW 0.8×50 PPTW 0.8×35 |
|
| DMRW 0.7×70 PPRW 0.8×35, DMRW 0.7×70 PPRW 0.7×30, DMRW 0.7×50 PPRW 0.8×35, DMRW 0.7×50 PPRW 0.7×30, DMRW 0.7×40 PPRW 0.8×35, DMRW 0.7×40 PPRW 0.7×30 |
|
| DMTW 0.7×70 PPTW 0.8×35, DMTW 0.7×70 PPTW 0.7×30, DMTW 0.7×50 PPTW 0.8×35, DMTW 0.7×50 PPTW 0.7×30, DMTW 0.7×40 PPTW 0.8×35, DMTW 0.7×40 PPTW 0.7×30 |
|
| DMRW 0.6×70 PPRW 0.7×30, DMRW 0.6×70 PPRW 0.6×25, DMRW 0.6×50 PPRW 0.7×30, DMRW 0.6×50 PPRW 0.6×25 |
|
| DMTW 0.6×70 PPTW 0.7×30, DMTW 0.6×70 PPTW 0.6×25, DMTW 0.6×50 PPTW 0.7×30, DMTW 0.6×50 PPTW 0.6×25 |
|
| Chin |
DMRW 1.2×70 PPRW 1.2×30, DMRW 1.2×50 PPRW 1.2×30 |
| DMTW 1.2×70, PPTW 1.2×30; DMTW 1.2×50, PPTW 1.2×30 |
|
| DMRW 1.1×70 PPRW 1.2×30 |
|
| DMTW 1.1×70 PPTW 1.2×30 |
Keywords:
Single-use sharp-ended injection needles and accessories
Single-use sharp-ended injection needles and accessories
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