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These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body. Intra-uterine transfer - 1) Frydman Catheter 4.5, 5.5 - 2) Frydman Catheter 4.5 with 2 lumen and removable mandrel - 3) Long Frydman Set - 4) Frydman Set - 5) Soft Frydman Set - 6) Soft Frydman Set with madrel - 7) TDT Set Intra-fallopian transfer - 1) Biset for GIFT - 2) Gift Catheter - 3) Oliver Set - 4) Rinsing Valve for Oliver Set

The Assisted Reproduction microtool devices have been down classified FR Vol. 63, No. 175 September 10, 1998. Effective date: October 13, 1998. As found in the labeling/promotional material: Frydman™ Catheter: Polyethylene catheter with a flexible end, internal diameter: 1.1mm, outer diameter: 1.6mm, and a distal opening. Double Lumen Frydman™ Catheter 4.5: Polyethylene catheter, 17.5cm long, consisting of a central tube 2.1mm, stiffened in its proximal part on 13cm by a second polypropylene tube 2.6mm, with two hysterometric markings at 5.5 and 6.5 from the distal opening. The central tube is a double lumen tube: its lateral lumen is provided with a malleable mandrel, and its central lumen 1.1mm, is intended to contain embryo(s). Soft Frydman™ Set (with or without mandrel): The set includes 2 catheters: Catheter Nº 1: Polypropylene introducer (with a blue adapter), Catheter Nº2 Polyurethane reimplantation catheter, Mandrel, 17.5 cm long, depending on the model. Short Frydman™ Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter). Long Frydman™ Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter). T.D.T.TM Set (for difficult embryo transfer): The set includes 2 catheters: Catheter No. 1 polypropylene introducer, Catheter No. 2 ultra-thin polyethylene reimplantation catheter. BI SET™ for GIFT: The set includes 2 catheters: Catheter No. 1 introducer (with an blue adapter), Catheter No. 2 polyethylene reimplantation catheter (with an orange adapter), Stainless steel trocar (with green adapter), 20 cm long. Two models are available: 1 transfer catheter, 2 transfer catheters. Oliver Set MK II ™: The set includes: 1 polyamide, echogenic, introducer, 24 cm long, 1.9mm, 1.1mm, pre-curved at 45°, with an loive-shape tip fitted with a ground stainless steel ring, 1 metal mandrel, 27 cm long, 1mm, 1 polyethylene transfer catheter, 33 cm long, 1mm, 0.6mm. Function of Device/Significant Physical Characteristics of Device: All devices are malleable, to allow a change in shape for the device; the mandrel is accluded to prevent the in-flow of bodily fluids when inserting into the crevix. All devices contain echolocater ultrasound markers.