China Supplier Medical Products Endoscope Accessories Disposable Stone Extraction Balloon Catheter Rapid Exchange for Ercp with CE Mark FDA ISO FSC

• Sterilization: Sterilization
• Feature: Disposable
• Application: Clinical
• Material: Plastic
• Certification: CE, FDA, ISO13485
• Power Type: Without Power
• Model NO.: SD-10-S121518A
• Group: Adult
• Channel O.D.: 3.2mm
• Balloon Max.O.D.: 12mm-15mm-18mm
• Tube O.D.: 7.5 Fr
• Working Length: 2000mm
• Triple Lumen Tube Color: Blue
• Transport Package: Bag+Inner Box
• Specification: 160mm*104mm for individual product packaging
• Trademark: With logo or without logo
• Origin: China, Zhejiang Province
• HS Code: 9018903090
• Production Capacity: 1000000PCS/Year

Product Description

Balloon stone extraction catheter intended to be used to sweep or capture pancreatic duct stones to deliver stone, sludge, and debris out of the duct system. The disposable stone extraction balloon is engineered to optimize time due to its puncture resistant balloon material, allowing to be pulled against sharp edged stones. The rounded balloon shape facilitates good occlusion due to its multiple sizing with rapid inflation and deflation times.
                                                                                                                                   
Features:

Retrieval Balloon Catheter
The squared shoulder of the Extractor balloon is designed to facilitate effective and efficient stone removal. 

Enhanced Balloon Design
New and improved balloon is designed to improve strenght and reliability.
Each of the three balloon sizes 8.5-15mm; 9-16mm to better accomodate anatomical variation and help obivate the need to use an additional balloon and change catheters if an alternative balloon diameter is requirered.
Squared shoulders balloon is designed to facilitate stone removal.

Improved Catheter Design
Designed for excellent injection flow rate.
Catheter is designed to be easily back loaded over a guide wire.

About Soudon Medical:

Soudon Med is a technology-driven enterprise that specializes in Research and Development of endoscope accessories , production technology as well as OEM and ODM service. Our delivery time averages three weeks and samples can be delivered within three working days. We have a 5,000 square meter clean workshop, and our production lines are systematically supervised by our quality team - starting from material procurement to the final stage of shipment. As a result, all products are made with the highest quality standard and have passed the stringent SFDA audit. More than that, some of our products have acquired CE and FDA certifications, while the rest are in the process of obtaining MDR and FDA certifications before the end of this year. We endeavor to appreciate customer needs with the most satisfying customer service and high-end quality assurance.

FAQ:

Q: Are you trading company or factory?
A: We are a factory, with more than ten years of experiences of manufacturing medical consumables like the guidewire endoscopy..

Q: Can you provide free samples?
A: Yes. Usually we have several quantity in stock, if need testing sample urgent, we will send within 3 work days.

Q: Are you able to get the certificate authorized by local Camber of International Commerce? 
A: Yes.

Q: What kind of certificates have you got?
A: FDA,CE, ISO13485, SGS. 

Q: Can you provide Letter of Authorization?
A:  Yes. Valid date within two years.

Q: Can you help registration?
A: Yes, we will provide related document after sign the cooperation agreement.

Main Specification:
 

Part No.	Channel OD (mm)	Balloon MAX OD  (mm)	Volume (ml)	Exchange	Tuebe OD (mm)	Length (cm)	Triple Lumen Tube Color
SD-10-T121518A	3.2	12~15~18	1.6~2.6~5	Triple (T)	7.5Fr	200	Blue(A)
SD-10-T91215B	3.2	9~12~15	1.1~2.2~3.5	Triple  (T)	7.5Fr	200	Gray(B)
SD-10-S121518A	3.2	12~15~18	1.6~2.6~5	With Rapid Exchange(S)	7.5Fr	200	Blue(A)
SD-10-S121518B	3.2	12~15~18	1.6~2.6~5	With Rapid Exchange(S)	7.5Fr	200	Gray(B)