Waston CE and FDA Certificated Endoscopic Stapler Surgical Stapler

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Waston CE and FDA Certificated Endoscopic Stapler Surgical Stapler

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Product Description

Basic Specifications

Model NO.

HSD Series

Certification

CE, FDA, ISO13485

Sterilization

Ethylene Oxide Sterilization

Application

Hospital Use

Group

Male, Female

OEM Support

100% OEM/Semi Finished Supply

HS Code

9018909000

Production Capacity

500,000 PCS/Year

YiTian Disposable Endoscopic Stapler

Product Code	Model	Color	Suture Length ±5	Cutting Length ±5	Staple Height	Staple Width
12029302	HSZ-30-WT(R)	White	30	25	2.5/3.0	3
12029303	HSZ-30-PT(R)	Purple	30	25	3.5/4.0
12029454	HSZ-45-PT(R)	Purple	45	40	3.0/3.5/4.0
12029455	HSZ-45-BT(R)	Black	45	40	4.0/4.5/5.0
12029603	HSZ-60-WT(R)	White	60	55	2.0/2.5/3.0
12029604	HSZ-60-PT(R)	Purple			3.0/3.5/4.0
12029605	HSZ-60-BT(R)	Black			4.0/4.5/5.0

Features & Benefits

Gentle tissue compression before firing minimises tissue trauma and supports repositioning.
Cutting knife housed within the reloading unit guarantees even distance between anvil and cartridge.
Cartridge lock out safety mechanism prevents use of fired reloading units.
Universal handle available in three size options and compatible with all reloading units.
Strong, thin anvil for simple and easy insertion.
Tissue stop prevents tissue from passing over the cut mark ensuring effective staple formation.
Single handed finger rotation wheel provides 360° revolutions.
Safety interlock prevents the device from being fired until the green 'Pre-Fire' button is pressed.
Ergonomic firing handle with rubber grip for surgeon comfort and control.

Manufacturing & Quality Control

As a national high-tech enterprise, the proportion of R&D investment to total sales has been over 8% for consecutive years. The facility operates strictly according to the ISO13485 quality system and CE MDD 93/42/EEC directive implementation.

Equipped with German-imported and American-imported machining centers and Japanese-imported automatic lathes, the testing center includes a biomechanical laboratory and a physical-chemical testing center for rigorous quality control.

Frequently Asked Questions (FAQ)

Q1: What certifications does the disposable endoscopic stapler have?

The product is fully certified with CE, FDA, and ISO13485 standards, ensuring it meets international medical safety requirements.

Q2: Does the manufacturer support OEM services?

Yes, we support 100% OEM and semi-finished supply to meet specific branding and market needs for global partners.

Q3: What is the sterilization method used for these staplers?

All endoscopic staplers undergo Ethylene Oxide (EO) sterilization to ensure they are safe for hospital and surgical use.

Q4: Are the handles compatible with different reloading units?

Yes, the universal handle is designed to be compatible with various reloading units, providing flexibility during different surgical procedures.

Q5: How does the safety mechanism work?

The device incorporates a safety interlock that prevents firing until the 'Pre-Fire' button is pressed. It also includes a cartridge lock-out to prevent the use of already fired reloads.

Q6: What is the annual production capacity?

The facility has a robust production capacity of approximately 500,000 pieces per year, ensuring a steady supply for international markets.