Identification of the person placing the product on the market
Nestmar Medical Ltd.
EIK
206260081
BG
SOF
Sofia
1415
Okolovrasten put N42
Slavi Nestorov
0878112319
office@nestmarmedical.com
Identification of the wholesaler
Nestmar Medical Ltd.
EIK
206260081
BG
SOF
Sofia
1415
Okolovrasten put N42
Slavi Nestorov
0878112319
office@nestmarmedical.com
BG/WDA/MD-0328
30/11/2020
General medical information about the device
10 - Single-use devices
Class ІІ a
Genito urinary system and sex hormones
GMDN
38821
Navigator Ureteral Access Sheath Sets
Description of the medical device
1
Sterility, Hospital prescription
Intended action by the manufacturer
Provides ureteral dilation and a working channel for
ureteroscopes and devices during procedures. Flexible tip, higher durometer dilator and sheath with additional sizes. Hydrophilic coating on sheath and dilator is designed for durability in bilateral cases and allows for ease of insertion. Dual durometer dilator – stiffer body facilitates placement in tortuous anatomy with flexible tip designed to reduce trauma during insertion and dilation. Kink-resistant sheath designed to provide stability and strength during placement. Radiopaque marker band on sheath tip helps enhance visibility under fluoroscopy.
