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The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity. The stylet is intended to be used with Vitrolife's Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.

Vitrolife´s Embryo Transfer Catheter (ETC) Assortment consists of three embryo transfer catheters (ETCs), one pre-curved variant (Model 17500, 230 mm) and two straight variants (REFs 17501, 17502) in different lengths (180 mm and 230 mm); and two stylets (Stylets) (REFs 17510, 17511) in different lengths (180 mm and 230 mm). ETC and Stylet are sterile, single-use devices used to deliver in vitro fertilized embryos to the uterine cavity. Embryo Transfer Catheter consists of: - A guide, also referred as outer sheath. The guide is used to navigate through the cervix canal. The guide has a distance marking, a stopper and a rounded tip to facilitate proper positioning. The guide is available in two different variants: - Pre-curved - stiff - Straight - soft and malleable - A catheter, also referred as inner catheter. The catheter is loaded with the embryo(s) in a small volume of transfer medium and inserted through the guide to gently deposit the embryo(s) into the uterine cavity. The transfer catheter is soft, flexible and approximately 50 mm longer than the guide. The tip of the catheter has an echogenic marking to enable ultrasound guidance. Embryo Transfer Catheter Stylet consists of: - A plastic-coated metal wire, which is malleable. The stylet is an accessory that can be used together with Vitrolife's guides to make them stiffer. The 17500 variant includes a stylet. The 17501 and 17502 variants do not include stylets, but the stylet can be purchased separately.

The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.

The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans. The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.

Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

Ultra RapidWarm Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose. The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.

SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets. The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations. The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets. The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations. The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.

The Extroducer™ Infusion Catheter System is a minimally invasive device for administering diagnostic or therapeutic solutions through the vascular wall directly to perivascular tissue of adult patients. At the selected site, the device is used to penetrate through the vascular wall into the tissue requiring treatment. The diagnostic or therapeutic solution is then delivered through the device. The device is sterile and designed for single patient use only. The device is to be used in hospital operating theaters and catheterization labs under normal clinical conditions, only by physicians trained in its use. The duration of use is no more than 60 minutes. The Extroducer™ Infusion catheter system consists of two main parts: An infusion needle with a needle hub and radiopaque marker and An outer protective sheath to protect the needle during positioning of the device, with a haemostatic valve to secure the infusion needle during use.

Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination. Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer. Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.

The subject devices are culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures handled by IVF professionals. The media are aseptically filtered into gamma sterilised PETG bottles with HDPE closure and a tamper evident seal and tested for pH, osmolality, embryo toxicity, endotoxins, and sterility.

SWEDEN & MARTINA SURGICAL TRAY (Model "ZSHORTY-INT") is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets. The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 ℃ (273 ℃) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes. The validated load weight is 230 grams.

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RapidVit™ Oocyte: Media for vitrification of human oocytes (MII). RapidWarm™ Oocyte: Media for warming of vitrified human oocytes (MII).

Two sets of media are covered by this 510(k), the RapidVit™ Oocyte for vitrification of oocytes and the RapidWarm™ Oocyte for warming of vitrified oocytes. RapidVit™ Oocyte contains three medium solutions to be used sequentially during oocyte vitrification. RapidWarm™ Oocyte includes four medium solutions to be used sequentially during oocyte warming.

PRAMA White Implant Systems are intended for both one- and two-stage surgical procedures. PRAMA White Implant Systems, endosseous implant and abutments, are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. PRAMA White Implant Systems are intended to be used in fully edentulous or partially edentulous maxillary and/or mandibular arches.

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Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MI).

Rapid-i™ Kit is a modified version of the predicate device (K140207). This device is a cryopreservation storage device intended for embryo/oocyte vitrification. Rapid-i™ Kit is provided sterile and is for single-use only. This device consists of the following items: - Rapid-i Stick – A 80 mm long Polymethyl methacrylate (PMMA) stick with a 0.4 mm diameter hole located near the distal tip of the device. The hole on the stick is used to hold one to five embryos or oocytes for vitrification in a 30 nL drop of vitrification medium. Users suspend samples across the hole via surface tension. Therefore, the medium containing the samples only touches the periphery of the hole. The stick has one flat side that aids in correct orientation of the device during oocyte/embryo loading procedures. - RapidStraw A 130 mm long Mediprene straw equipped with a stainless steel weight to maintain device orientation in liquid nitrogen (LN). The straw has a flared open end to allow for insertion of the Rapid-i Stick. This component functions as a protective sleeve around the Rapid-i Stick to prevent direct contact with LN during loading and after sealing the open end with an ultrasonic sealing device. - Stainless steel rod - This 115 mm long stainless steel rod resides within RapidStraw during pre-cooling procedures in LN. It aids in keeping RapidStraw straight in LN during pre-cooling. Rod removal occurs 20-30 seconds prior to Rapid-i Stick loading into the RapidStraw.