【Product Name】

Disposable Ureteral Guide Sheath

【Applicable Model】

UAS-10Fr-3、UAS-10Fr-4、UAS-11Fr-3、UAS-11Fr-4、UAS-12Fr-3、UAS-12Fr-4、UAS-13Fr-3、UAS-13Fr-4、UAS-14Fr-3、UAS-14Fr-4

【Registrant/Information of manufacturer】

Registrant/Manufacturer/After-sales service :

ANHUI AEROSPACE BIOTECHNOLOGY CO.,LTD.

Domicile : Comprehensive Workshop 1, No. 1319 Shanxiang Road, Bengbu City, Anhui Province

Manufacturer Address: No.1319 Shanxiang

Road,High-tech Zone ,Bengbu City

Manufacturer License Number: Anhui Drug Administration Production License NO. 20150011

Registration Number/Product Specification Number: MPA.AH Certified No.20202020443

TEL:+86-400-0552-689

【Product Performance】

The fracture force of the dilatation tube and the connection between the dilatation tube and the seat should not be less than 50N.

The fracture force of the guide sheath and the connection between the guide sheath and the seat shall not be less than 30N.

The product should be sterile.

The residual amount of Ethylene Oxide should be less than 10μg/g.

The dilatation tube shall be X-ray impervious.

【Main structure or composition】

It consists of guide sheath coated with hydrophilic coating , dilatation tube, guide sheath seat and dilatation tube seat. The inner wall of the guide sheath is made of PTFE, the outer wall of the guide sheath is made of PEBAX, and the middle layer is made of 304 stainless steel; The dilatation tube is made of low-density polyethylene and Barium sulfate (X-ray development); The guide sheath seat is made of ABS, and the dilatation tube seat is made of PP.

After sterilization with Ethylene Oxide, the product should be sterile.

【Scope of application】

It is used to establish the channel for endoscope and other instruments to enter the urinary tract during Urology.

【Contraindications】

There are no known contraindications.