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V-DENUPET is used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of oocytes and embryos during assisted reproductive techniques (ART). V-DENUPET is not intended for biopsy of cells from oocytes or embryos.

The V-DENUPET is a polycarbonate micropipette. All tips are 90 mm in length, and depending on the size of the tip have a volumetric capacity of 20-25 µl. All pipettes have an outer diameter of 900 µm at the proximal end that is connected to an aspiration device. The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below: - Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation. - Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling. V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.

EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos. The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.

The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl. Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below: - Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling - Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable. The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting. The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.

InteGlobal MicroTips TPLG-130 are used for Denuding, handling blastomeres, oocytes and oocyte stripping. LifeGlobal MicroTips TPLG-180, TPLG-225 and TPLG-275 are used for handling embryos and blastocysts.

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The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection. The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection. The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.

The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time use.

The Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, occyte and embryo manipulation, or denuding. The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.

The Flexipet® Denuding Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 120 µm to 170 µm on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use. The Flexipet® Manipulation Pipettes are polycarbonate tubes with inner diameters measuring 600 um (microns) at the proximal end which taper in diameter in a range from 80 um to 600 um on the distal end. The micropipettes are all 3.5 inches in length and constructed from polycarbonate. The devices are supplied gamma sterilized and are intended for one-time use.

Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).

The Biopsy pipette is part of the RI Pipettes range. Other pipettes available in this range include ICSI Injection, ICSI Holding, and Assisted Hatching pipettes. Biopsy pipettes are offered in a range - ID sizes - 14μm, 20μm, 25μm, 30μm, 40μm . - bend angles 0°, 15°, 20°, 25°, 30°, 35°, 40°, 45° . - . tip profiles - flat , non-spiked (bevelled), spiked All pipettes in this range are manufactured from very fine borosilicate glass, packed individually into a Twista-Pak (primary packaging) and sealed in a medical pouch. They are then batch sterilised by gamma irradiation.

The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows: Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI) Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s) Polar Body Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s) Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically

The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. - a. Injection pipette; - b. Holding pipette; - c. Biopsy pipette; - d. Polar body biopsy pipette; - e. Denuding pipette; - f. Partial zona dissection (PZD) pipette; - g. Assisted hatching (AH) pipette.

Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s). Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight. The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences. These devices are intended for one-time use and will be marked sterile. These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.