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[Production License Number] Sujiang Medical Device Production License No. 20240191
[Product Registration Certificate Number] Surgical Instrument Registration No. 20252022177
[Product Technical Requirements Number] Surgical Instrument Registration No. 20252022177
[Product Name] Single-use cannula puncture device and kit
【Model Specifications】
Single-use cannula puncture devices and kits are classified by configuration as follows: single-unit packs in sizes 3#, 5#, 10#, 12#, and 15#; and kit sets in types A, B, C, D, E, F, G, H, I, J, K, L, M, and N.
[Product Performance and Structural Composition]
Single-use puncture devices and kits are classified according to configuration into single-unit puncture devices and kits. A puncture device consists of a puncture needle (including the needle cannula and needle holder) and a puncture sheath (comprising the outer sheath, air-lock valve, sealing valve, sealing cap, and insufflation valve). Kits are assembled in various configurations, comprising puncture devices, insufflation needles, and retrieval bags in different quantities. This product is supplied in a sterile condition and is sterilized by ethylene oxide; the residual ethylene oxide level shall not exceed 10 μg/g. It is for single use only.
[Product Illustration]
1. Puncture needle 2. Puncture cannula 3. Puncture needle tube 4. Outer sheath of the puncture tube 5. Air-lock valve 6. Sealing valve
7. Sealing cap 8. Puncture needle holder 9. Inflation valve
Figure 1: Typical Puncture Device Structural Configuration
【Scope of Application】
For use during clinical laparoscopic examination and surgery to puncture the abdominal wall tissue and establish a working port for laparoscopic procedures.
【Contraindications】
1. Severe cardiovascular disease, cardiac dysfunction, and impaired pulmonary function;
2. Diffuse peritonitis, hernia, failure, or shock (relative); 3. Coagulation disorders, hematologic diseases, massive ascites, and internal bleeding; 4. Severe intestinal distension, extreme obesity, and a history of multiple laparotomies.
5. Palpable mass in the lower abdomen, with gestational age of more than 4 months; 6. Hepatitis, severe diabetes mellitus, and hyperthyroidism; 7. Insufficient abdominal insufflation, abnormal pelvic anatomy, infection, and coagulation disorders.
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Single-use cannula puncture device and kit
Single-use cannula puncture device and kit
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Jiangsu Kebang Bioscience Co., Ltd.
Address: Yangzhou Health and Medical Industry Park, Touqiao Town, Guangling District, Yangzhou City