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The CrossGlide™ ETS Plus is indicated for use for sonohysterography and to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

The CrossGlide™ ETS Plus is a sterile, disposable, single-use device which enables saline infusion sonohysteroraphy and the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS Plus contains a Delivery Catheter with an everting Membrane, an Inner Aspiration Catheter that contains a lumen for saline infusion and aspiration. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. A proximal luer connector allows a 10cc luer lock syringe to infuse saline into the uterine cavity for sonohysterography. The 10cc syringe can be used to remove the saline from the uterine cavity and create negative pressure. Movement of the CrossGlide™ ETS Plus device, after creating negative pressure with the 10cc syringe, removes material and tissue from the uterine cavity.

The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.

The CrossGlide™ ETS, Endometrial Tissue Sampler, is a sterile, disposable, single-use device which enables the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS contains a Delivery Catheter with an everting Membrane and an Inner Aspiration Catheter. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. Movement of the ETS device, after creating negative pressure with the 3cc syringe, removes material and tissue from the uterine cavity.

The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are: - Treatment of cervical stenosis - IUD placement and removal - Placement of instruments for intrauterine radiotherapy - Endometrial biopsy - Global endometrial ablation - Uterine tissue removal - Uterine curettage - Diagnostic hysteroscopy - Operative hysteroscopy This device is not intended for use in the induction of labor.

The CrossBay Cervical Dilator Catheter System is a sterile, single use device composed of an inflation device, dilator catheter, everting membrane, and dilator balloon which enable softening and dilation of the cervical canal. The CrossBay Cervical Dilator Catheter System contains an Inflation Device and a Dilator Catheter that accesses the cervix using a hydraulic pressure-filled everting Membrane. The Inflation Device provides the hydraulic energy with saline supplied by the user. Once placed at the exocervix, the Dilator Catheter advances through the cervix by everting the Membrane through the endocervix. A Dilator Balloon is attached to the inner tube of the device that is positioned across the cervix when the everting Membrane is fully everted. The Inflation Device is then used to further pressurize the system to split open the everting Membrane to expose the Dilating Balloon. The Inflation Device is used to pressurize the Dilator Balloon to the prescribed level. Once dilated, the Dilator Catheter is removed from the cervix and the subsequent uterine cavity procedure can commence. The CrossBay Cervical Dilator Catheter with Dilator Balloon is provided in three sizes of 5mm, 7mm, and 9mm. The three sizes are identical except for the diameter of the Dilator Balloon when pressurized.

The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

The CrossBay IVF Embryo Transfer Catheter Set is a sterile, single use device composed of disposable components supporting the transfer of an in vitro fertilized embryo to the uterus. The CrossBay IVF Embryo Transfer Catheter Set is comprised of a Delivery Catheter with a 6 Fr Inner Catheter and everting membrane that accesses the cervix and uterine cavity; a 3cc syringe for supplying aseptically filtered media or saline to the Delivery Catheter; and a 3 Fr Embryo Transfer Catheter that is supplied in a separately sealed pouch. The Delivery Catheter contains an acorn tip for seating the distal end of the Delivery Catheter at the exocervix. The Embryo Transfer Catheter contains a stainless steel band at the distal end to provide additional echogenicity to the catheter for ultrasound guided procedures. The Embryo Transfer Catheter has markings on its proximal end at 1 cm intervals to aid in determining the depth of insertion. The Embryo Transfer Catheter can extend a maximum distance of 4 cm beyond the distal end of the fully everted membrane when completely inserted into the Delivery Catheter. The maximum insertion depth of the Embryo Transfer Catheter and fully everted membrane is 9 cm.

The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill salineonly or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.

The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.

The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.