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The Cryotop® Vitrification Kit is indicated for use in the preparation, and storage of promuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. The Cryotop® Thawing Kit is indicated for use in the preparation and thawing of vitrified pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The Cryotop® Vitrification and Thawing Kits are composed of a set of five media to vitrify and warm pronuclear (PN) through blastocyst stage embryos for Assisted Reproductive Technologies (ART) procedures. The Cryotop® Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then in VS. Using this methodology, the permeating cryoprotectants can replace water in the PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen. The Cryotop® Vitrification Kit comes pre-packaged with one 1.5 ml vial of ES, two 1.5 ml vials of VS, 4 Cryotop devices (Cryotop SC, or Cryotop US), and two Repro Plates. The Cryotop® Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified PN through blastocyst stage embryos. The Cryotop® Thawing Kit is composed of TS (Thawing Solution), DS (Dilution Solution) and WS (Wash Solution). The Cryotop Thawing Kit comes pre-packaged with two 4.0 ml vials of thawing solution, one 4.0 ml vial of dilution solution, one 4.0 ml vial of washing solution, one Repro Plate, and two 35 mm dishes. All of the media in the Cryotop® Vitrification Kit and Cryotop® Thawing Kit contain Gentamicin. The media in these kits undergo aseptic filtration, while storage devices are sterilized by radiation.

PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60. PBS(-) composition: - Sodium Chloride - · Potassium Chloride - Monopotassium phosphate - Di-sodium Hydrogen Phosphate Anhydrous PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.

Mineral Oil is used as an overlay for culture of embryos, oocytes, and sperm in assisted reproduction technology (ART) and micromanipulation procedures.

Mineral Oil is used to cover medium during embryo, oocyte, and sperm culture in assisted reproduction technology (ART) and micro-manipulation procedures. Mineral Oil is recommended for use as an overlay for a small volume of medium to prevent evaporation stable osmolality and pH. The material composition: High Purity Paraffin Oil comes in two density types: - Light type has a ratio between 0.8200 to 0.8400 g/mL (15°C) and a viscosity which is between 8.850 to 11.70mm²/s (37.78°C) - Heavy type has a ratio between 0.8500 to 0.8700 g/mL (15°C) and a viscosity which is between 41.90 to 44.10mm²/s (37.78°C). There are two types of products, Mineral Oil - Light and Mineral Oil - Heavy. Two different unit sizes (100mL and 50mL) are available for each type. Mineral oils are colorless, tasteless, clear oil fluids which do not produce fluorescence. Both Mineral Oils (Heavy and Light) do not contact the ova or embryo during culture. Mineral Oil is filter sterilized and dispensed into sterile light-resistant glass bottles.

The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

CryotopUS is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopUS device for subsequent storage. The CryotopUS device is composed of an acrylonitrile butadiene styrene (ABS) handle shaft with a polyethylene terephthalate (PET) film tip and a polypropylene straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopUS device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The handle shaft is designed with a "stop" for inserting the film tip/shaft handle into the straw enclosure. A hermetic seal is created via a tapered shaft handle with a stop location integrated into the handle is placed into the straw enclosure this creates a closed system keeping the film tip isolated from the liquid nitrogen. The straw enclosure system has a weight at the distal end to place the straw and the shaft inside in a correct position in the liquid nitrogen. The CryotopUS device is provided sterile and is for single use only. The CryotopUS device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.

The Cryotop®SC is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.

CryotopSC is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. Extracting embryos from the body can be costly and burdensome process for the patient to go through multiple extraction procedures. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopSC device for subsequent storage. The CryotopSC device is composed of an ABS handle shaft with a PET fine tip and a straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopSC device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The straw cap has a weight at the distal end to place the straw cap and the shaft inside of the cap in a correct position in the liquid nitrogen. The CryotopSC device is provided sterile and is for single use only. The CryotopSC device has been designed to maintain the integrity of the human embryos through the freezing and thawing process. The Aluminum Block is required for use with the CryotopSC device for the vitrification and thawing process and is sold separately. The Aluminum Block is to be used with the CryotopSC device to prevent liquid nitrogen from entering the straw and to assist in stabilizing the manipulation of the straw. The CryotopSC device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopSC is validated by sterilization to maintain the sterility of the device through anticipated storage and handling.