CE Certified Disposable Endo Fascia Closure System with Manual Power Source

• Customization: Available
• Type: Basic Surgical Instruments Sets
• Application: Abdominal, Anorectal, Urology
• Model NO.: WPJM-13.5
• Material: Plastic, Steel
• Feature: Disposable
• Certification: ISO13485
• Group: Adult
• Warranty: Lifetime
• Power Source: Manual
• Effective Suture Length: 125mm
• Properties: Abdominal Surgery Equipments
• After-Sale Service: Online Technical Support
• MOQ: 1 Piece
• Logo: Customized Logo Accepted
• Safety Standard: ISO13485
• Function: Suture and Stitching
• Instrument Classification: Class II
• External Diameter of Suture Needle: 1.2mm
• Product Name: Endoscopic Fascia Closure System
• OEM: Avaliable
• Sterilization: Eo Sterilezation
• Shelf Life: 3 Years
• Transport Package: 1 Blister Box/1 PCS
• Specification: WPJM-13.5
• Trademark: Weiyuan
• Origin: Jiangsu, China
• HS Code: 9018909919
• Production Capacity: 1000 Piece/Pieces Per Day

Product Description

Application & Feature

STEP 1
Deploy the device
Gently insert the device into the defect and skillfully utilize the slide lock to secure the wing shields in place. Once the wings have firmly locked, position them delicately against the abdominal wall. Ensure the suture retriever exit line is strategically placed below skin level to guarantee optimal suture purchase, setting the stage for a seamless procedure.

STEP 2
Retrieve the suture
Fully insert the suture retriever deep into the guide channel, and press the black suture retrieval button until it audibly locks into place, expertly capturing the suture. Remove the retriever and press the reset button, preparing to repeat this efficient process on the other side, showcasing precision and reliability.

STEP 3
Collapse and close
Masterfully reposition the slide lock to smoothly collapse the wing shields, facilitating the effortless removal of the device from the defect. Secure both ends of the suture with finesse and tie using your preferred method, culminating in a closure that is both secure and impeccable.

 

Product Feature

1. Suture retriever button

Ingeniously designed to ensure the capture and retrieval of suture strands is both rapid and secure, enhancing operational efficiency.

2. Slide lock

Effortlessly facilitates wing deployment and approximation, making complex maneuvers look simple and efficient.

3. Finger grip pads
Ergonomically designed for precise and comfortable device control, ensuring ease of use throughout the procedure.

4. Suture anchors
Enable quick and secure suture loading, streamlining the process and enhancing user convenience.

5. Retraction wings
Engineered for improved retraction and stability, these wings enhance security and control on the abdominal wall.
6. Suture retrieval wing shields
Provide superior sharps protection and facilitate safe suture retrieval. The shields allow for precise and accurate placement 1 cm lateral to the defect midline, ensuring safety and accuracy.

Products Show

Product Parameters

Product Name	Disposable Endo Fascia Closure System
Model No.	WPJM-13.5
Appearance	Smooth appearance, soft, clear outline, no burr, flying edge, scratches, shrinkage and other defects Be in good condition, free from damage, contamination and air bubbles
Feature	Help surgeons to close port site easily, fast and safe in laparoscopic endoscopic surgery  Effectively minimizes post-operative complications including infection, bleeding, and port site hernia  High precision and good surface treatment
Performance	The tip of the suture needle should have no empty tip. After the tip is loaded with 0.98N top pressure at the afterloading speed of 10g/s, there should be no bending hook. And needle puncture force should be less than 10N
Package	Aseptic packaging shall be intact and the bonded sealing area shall be free of channels or perforations The peel strength of the packaging seal shall not be less than 0.1 N/mm, the two contact surfaces shall be smooth and continuous and uniform without lamination or tearing
Sterility	Sterilized with confirmed ethylene oxide and product should be sterile
Residual EO	After sterilization with ethylene oxide, the residual ethylene oxide should not be more than 10μg/g

 

Company Profile

Our Advantages

Why choose us?

1. Professional global regulatory consulting team

Under the visionary leadership of Dr. Louis Li, our consulting team boasts over a decade of stellar experience in medical device quality management and global product registration. Dr. Li's illustrious career includes roles as Quality Engineering Supervisor at Zimmer Biomet, Management Representative and QA Manager at Medtronic Comfort, and Quality Regulation Director at Scion US and Cylon China. His extensive expertise includes successful completion of numerous F*D*A 510K applications, CE product registration in the EU, and coordination of several pivotal F*D*A audits in the United States, as well as comprehensive international audits by ANVISA in Brazil.
international audits by ANVISA in Brazil.

2. Very good relationship with manufacturers in China

We have expertly assisted Chinese factories in obtaining CE/ISO/F*D*A certification, ensuring they maintain these essential certifications annually. Through our strategic investments as a small shareholder in several factories, we maintain strong cooperative relationships, allowing us to offer direct factory wholesale prices.

3. Professional research & development, quality control and sales team

We maintain robust connections with leading global medical companies, exchanging insights and staying abreast of cutting-edge medical industry technology and products. Our team, comprised of highly educated professionals, actively participates in industry summits to continuously enhance their expertise.
industry technology or products. Most of our employees are highly educated.

Certifications

FAQ

Q: Who are we? A: We are Weiyuan Medical Devices Co.,LTD, not only a stable professional supplier of medical devices in China. Q:What is your strength in this field? A:We are also expert in working CE/ISO certificate of medical devices with quality control and regulatory team. Q:Do you provide samples? Is it free or extra? A:Yes, we can provide free samples while you pay the shipping cost to abroad. Q: How long is your delivery time? A: Generally, we need 15 days before delivery. It is about one week if the goods are in stock. Q:Does your product have a warranty period? A:We give 3 year warranty.

Q:What is your payment method? A: T/T, Western Union, Money Gram, PayPal and Trade Assurance Service.

Packing & Delivery

 

 

 

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