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[Production License Number] Sujiang Medical Device Production License No. 20240191
[Product Registration Certificate Number] Su Medical Device Registration No. 20252062104
[Product Technical Requirements Number] Su Medical Device Registration No. 20252062104
[Product Name] Single-use Specimen Retrieval Bag for Endoscopes
【Model Specifications】
Single-use endoscopic specimen retrieval bags (hereinafter referred to as “retrieval bags”) are classified into two models, Type A and Type B, based on their composition. The specifications, determined by the bag’s capacity, are as follows: large size—420 mL; medium size—320 mL; small size—200 mL.
【Structural Composition】
Single-use endoscopic specimen retrieval bags (hereinafter referred to as “retrieval bags”) are classified into two models, Type A and Type B, based on their composition. Type A consists of a bag body, a sheath gun assembly (including a steel blade, sheath sleeve (A), plug, handle, sheath sleeve (B), connector, retrieval rod, and grip), a pull ring, and a pull cord; Type B consists of a bag body, a pull ring (optional), and a pull cord. The product is supplied in a sterile condition, sterilized by ethylene oxide, and intended for single use only.
【Product Performance】
Ethylene oxide residue: ≤10 μg/g.
The structural composition of this product is shown in the figures below: Type A—Figures 1 and 2; Type B—Figure 3.
Figure 1 Bag Body
1—Bag body, 2—Steel plate, 3—Gun barrel sleeve (A), 4—Plug, 5—Pull ring, 6—Handle, 7—Gun barrel sleeve (B), 8—Connector, 9—Pull cord, 10—Object-picking rod, 11—Handle
Figure 2: Single-use specimen retrieval bag for endoscopes (Type A)
1- Bag body, 2- Pull tab, 3- Pull string
Figure 3: Single-use Specimen Retrieval Bag for Endoscopes (Type B)
【Scope of Application】
Used in endoscopic surgery to remove tissue and/or biopsy specimens from the surgical site.
【Contraindications】
1. Various conditions that are not suitable for laparoscopic surgery;
2. Laparoscopic surgical resection shall include tissues with sharp or cutting edges.
Keywords:
Single-use Specimen Retrieval Bag for Endoscopes
Single-use Specimen Retrieval Bag for Endoscopes
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Jiangsu Kebang Bioscience Co., Ltd.
Address: Yangzhou Health and Medical Industry Park, Touqiao Town, Guangling District, Yangzhou City