Search Results

The SperSort™ Sperm Sorting Chip is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

The SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.

The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile. The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life. The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size.

The SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) procedures.

The SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) procedures. The SwimCount® Harvester separates the sperm sample by allowing motile sperm cells to pass the SwimCount® Harvester's membrane system. The SwimCount® Harvester has a design/technology that utilizes the motility of the sperm cells (i.e. swim-up nature) to separate the motile sperm cells from the rest of the sperm population. The SwimCount® Harvester has two processing volumes, 1 mL and 3 mL. The device consists of 3 compartments: 1) Sample compartment (1 mL or 3 mL), 2) Medium/Harvest compartment (0.8 mL for both device versions), and 3) Microporous polycarbonate (PC) filter membrane (10 um pore size). Each device version has a Semen Inlet port that communicates with the lower sample compartment. The sample compartment is separated from the upper collection compartment by the microporous filter membrane. Semen is added to the lower compartment through the sample inlet port and cleared sperm separation medium (not provided) is added to the upper collection compartment through the Medium Inlet port. After incubation, the separated motile sperm cells are collected from the upper collection compartment through the Harvest Outlet port and used for subsequent assisted reproduction fertilization procedures. The SwimCount® Harvester is supplied to the user as sterile (radiation), with a sterility assurance level of (SAL) of 10 6. The devices are individually packed and for single use only.

cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.

The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

Not Found

The SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.

SpermAlign is a sperm separation device used to prepare motile sperm for assisted reproductive technology (ART) procedures. Separation is achieved through a fluid filled microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilizes a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and sperm washing media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF) procedures. SpermAlign is sterilized using X-Ray irradiation and has a sterility assurance level (SAL) of 10-6. The devices are individually packaged and for single use only.

The Nest VT Vitrification Device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.

The subject devices, Cook Nest VT Vitrification Devices, are sterile, single-use assisted reproduction storage devices for use in vitrification procedures to contain and maintain oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life. During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.

The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm. The LensHooke Sperm Separation Device has a base and filter layers to separate and process the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port. The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.

The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.

The EmbryoSlide+ ic8 dish is single use, sterile for embryo culture, handling, and preparation for transfer during assisted reproduction technology procedures. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has eight culture wells. Each well holds a single embryo in 20µL of culture medium. In addition, four rinsing wells are available, each rinsing well holding 25-30μL medium. The culture area of the dish, comprising both the culture wells, must be covered with 1.6mL culture oil overlay to minimize osmolarity changes during culture in a dry environment.

The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos. The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.

Not Found