Address:Communication Center,Neve Ilan Central,IL
Device Description : GYNESCOPE , SYSTEM (CONSOLE, IMAGE ACQUISTION SYSTEM-1 pcs
Device Class : 2
Duns Number: 600627621
Premarket Exempt : No
Prescription Use : Yes
Device Description : Indications for UseGynescope single Use Vaginal Speculum The disposable vaginal Indications for UseGynescope single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system.
Device Class : 2
Duns Number: 600627621
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system
Device Class : 2
Duns Number: 600627621
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope™ system.
Device Class : 2
Duns Number: 600627621
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : 20 units with small size20 units with medium size20 units with lager size.Indica 20 units with small size20 units with medium size20 units with lager size.Indications for UseGynescope Single Use Vaginal Speculum The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal single use speculum can be used ONLY with the Gynescope system.
Device Class : 2
Duns Number: 600627621
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Gynescope™ systemconsole for image capturing and digital image archiving
Device Class : 2
Duns Number: 600627621
Premarket Exempt : No
Prescription Use : No
Device Description : The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution The Gynescope™ is an imaging colposcope. The Gynescope™ provides high resolution imaging optics comprised of multi-spectral (White and Green)illumination and multi-angle illumination dark field (side illumination) and bright field (centered illumination) techniques, reinforced with dual imaging sensordesign (a color imaging sensor and a high sensitivity monochrome sensor). The monochrome sensor and the color sensor have the same optical path. The opticaldesign uses a beam splitter adjacent to both of the sensors (at the end of the optical path).The Gynescope™ is a compact colposcope platform for physicians to performexaminations of the cervix, combined with a working space for interventionalprocedures. The Gynescope™ includes an Image Acquisition System
Device Class : 2
Duns Number: 600627621
Premarket Exempt : No
Prescription Use : Yes
Device Description : Gynescope system, cart
Device Class : 2
Duns Number: 600627621
Premarket Exempt : No
Prescription Use : Yes