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EIfClip™ Absorbable Hemostatic Ligation Clips for Endoscopic Surgery - China Suppliers & Factory
PRODUCT FEATURES
- Dual-layer clip lock mechanism: Latch on distal end of outer layer locks with the distal notch of inner layer to secure the clip, locking both layers together and ensuring ligating security.
- Distal end closure: The two-part compression closure mechanism ensures inclusion of the blood vessel in the clip and prevents the vessel from slipping out during the ligating process.
- Closing sequence: May provide a more secure closure than latch closure mechanisms by reducing the risk of tissue interposition.
- Radiotransparent: The clips do not interfere with the magnetic field of X-ray, CT or MRI scans.
- Innovative package design: Built-in desiccant to avoid unnecessary troubles.
PRODUCT DESCRIPTION
| Product Use | For ligation of cystic duct, arterial vessel with diameter of 5 mm or below. | Product Highlights | With a dual-layer structure, complete degradation and absorption in 39 weeks, degradation products of water and carbon dioxide. |
| Device Classification | [CN] Class III | Material | PGA, PDO |
| Specification Description | Different specifications represent 1, 2 and 3 clips in a package, respectively. | Storage Conditions | The product shall be stored in a cool, dry, well-ventilated and clean room without corrosive gas. And do not place it in an environment exceeding 40℃. |
PRODUCT SPECIFICATION
| Product name | EIfClipTM Absorbable Hemostatic Ligation Clips |
| Instructions | Open the paper-plastic package, take out the product and use it with the special clip applier. |
| Country of origin | China |
| Product structure and composition | Consists of four parts, namely inner card, outer card, barrel and plunger, in which the inner card and outer card are implantable parts, and the barrel and plunger assist the inner card and outer card to be implanted into human body. |
| Package | 1pc/bag, 2pcs/bag, 3pcs/bag (sterilized package) |
| Retention in the body | Degradable and absorbable |
| Visual identity | The inner and outer layers are designed in two distinct colors. The effect of clipping the tube cavity of the inner and outer layers is clear at a glance, avoiding misjudgment in actual using. |
| Product design | The raw material of the inner part is poly-dioxanone, which has good hydrophilicity and softness. It has no acute angle, which could avoid blood vessels damage or other tissue hazards. The two arms of the inner clip are provided with alternating rack, which is conducive to increasing the friction between the inner clip and the tubular tissue, so that the clamping is more firm and less falling off occurs. |
| Precautions |
• The product is for single use; it is not designed to be used in case of damaged package. • The product must not be used by unskilled or untrained personnel. |
| Shelf life | 2 years |
Figure 1. Absorption rate curves of outer and inner circlips products
Frequently Asked Questions (FAQ)
What is the primary application of EIfClip™ Absorbable Hemostatic Ligation Clips?
EIfClip™ is designed for the ligation of the cystic duct and arterial vessels with a diameter of 5 mm or below during surgical procedures.
How long does it take for the ligation clips to degrade and absorb?
The clips feature a dual-layer structure that undergoes complete degradation and absorption in the body within 39 weeks. The final degradation products are safely eliminated as water and carbon dioxide.
Will these clips interfere with post-operative imaging scans like MRI or CT?
No, the clips are radiotransparent, meaning they do not interfere with the magnetic fields or imaging results of X-ray, CT, or MRI scans.
What materials are used to manufacture the EIfClip™?
The clips are made from high-quality biodegradable polymers, specifically PGA (Polyglycolic Acid) and PDO (Polydioxanone). The inner part is made of poly-dioxanone (PDO) for optimal flexibility and tissue safety.
What are the storage requirements for this product?
The product must be stored in a cool, dry, well-ventilated, and clean room free of corrosive gases. The storage temperature must not exceed 40℃.
Can the clips be reused or sterilized again?
No, this product is strictly for single use only. It must not be reused, and it should not be used if the sterile packaging is damaged. It should only be handled by trained medical professionals.