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The embryo transfer catheter set is a sterile, single use device designed for in vitro fertilized (IVF) embryo transfer into the uterine cavity. The trial transfer catheter is a sterile, single use device which is designed for ensuring a free passage through the cervix prior to the embryo transfer. The stylet is a sterile, single-use device designed to support in initial placement of the guide catheter prior to the embryo transfer.

**Embryo Transfer Catheter Set:** The Swemed Embryo Transfer Catheter Set is manufactured by Swemed of medical grade polymers. The device consists of a two piece assembly comprised of an embryo transfer catheter and a detachable guide catheter (outer sheath). The overall length of the assembly ranges from 190 mm to 250 mm. The outer diameter of the transfer catheter is approximately 1.4 mm and the outer diameter of the guide catheter is approximately 2.3 mm. The catheter sets are packaged separately or assembled in an double barrier sterilisation pouch/wrapping. All devices are sterilized using e-beam irradiation. **Trial Transfer Catheter Set:** The Swemed Trial Transfer Catheter Set is manufactured by Swemed and is identical to the Swemed Transfer Catheter Set except for tip design and packaging configuration. The differences are that the tip is closed, i.e. no hole, and that it is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation. **Stylet:** The Swemed stylet is manufactured by Swemed of medical grade polymers and stainless steel. The stylet consists of a handle (polyurethane) and polymer (polytetraflourethene) covered stainless steel wire. The Swemed stylet is packaged in a single barrier, i.e. an outer sterilization pouch/wrapping only. All devices are sterilized using e-beam irradiation.

The Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s). The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of preimplantation genetic diagnosis. This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.

The Swemed Blastomere Pipette is manufactured by Swemed of borosilicate glass. The pipette has an inner diameter ranging from 0.030 mm to 0.049 mm and an outer diameter of either 0.053 mm or 0.060 mm. The pipette's length ranges from 55 to 65 mm. The Blastomere Pipette has a 20-35° beveled tip. The pipette is packaged in a silicone holder together with a glass tube. The tubes are then provided in seals made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.

The Swemed Follicle Aspiration Sets are intended to be used to obtain gametes from the body. The Swemed Follicle Aspiration Sets are indicated for use in flushing and/or aspiration of oocytes from ovarian follicles.

The Swemed Follicle Aspiration Sets are designed with either a single lumen which is capable for aspiration from the follicle or a double lumen which is capable of aspiration and flushing of sterile medium through the outer lumen up to the follicle. The needle has a beveled tip provided with shallow grooves to improve ultrasound image enhancement. The needle are supplied with a protective tube on the tip, which must be removed before use. The needles have inner diameters of 0.8 - 1.2 mm and outer diameters of 1.47 - 1.65 mm, which approximates a 16 and 17 gauge needle, respectively. The needle length ranges from 25 to 35 cm. The set is packed in an inner and outer wrapping, and steam sterilized.

The Swemed Pipettes are intended to be used to denude, micromanipulate, hold or transfer human gametes or embryos for assisted hatching, ISCI, or other assisted reproduction methods. The Swemed Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of occytes; the Swemed Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette; the Swemed Denuding Pipettes are used to remove the cumulus cell layers; and the Swemed Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching.

The Swemed Pipettes are manufactured by Swemed of borosilicate glass. The pipettes have inner diameters ranging from .0048 - . 190 mm and outer diameters ranging from . 0068 - . 280 mm. The pipette length ranges from 50 to 90 mm. The Denuding Pipette does not have a beveled tip. The ICSI, the holding, and the Assisted Hatching/Zona Drilling Pipettes have a 30-35° beveled tip. The pipettes are packaged in a rubber holder together with a glass tube. The tube is then provided in a seal made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.