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The Hushd Avera device is intended to reduce or alleviate snoring.

The Hushd Avera device is a removable intraoral non-patient specific device used for treating snoring. The device consists of multiple trays that fit over the upper and lower teeth. When the upper and lower tray engages, the device functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the tongue and soft tissues of the throat from collapsing into the airway.

The Hushd Avera device is a "Boil and Bite" device where both the upper and lower trays are constructed out of moldable soft ethylene vinyl acetate (EVA) material with rigid polypropylene (PP) outer shells.

Hushd Avera consists of one upper and two lower trays. Each upper tray contains a trapezoidal block on each side of the posterior to mate with the lower tray. An identification mark is placed on the blocks. The blocks and the outer shell of the upper tray are molded in one piece.

Each lower tray contains a vertical dorsal fin on each side of the posterior to serve as mating mechanism. The fins are triangular shaped at approximately 12.0mm(H) x 12.0mm(W) x 2.5mm(D). The mating surface of the fins are flat to ensure stable positioning of the upper and lower trays against each other. An identification mark is placed on the dorsal fins. The dorsal fins and the outer shell of the lower tray are molded in one piece.

There are no additional clip-on mechanisms connecting the upper and lower trays.

Relative to the upper tray (U), the first lower tray (L1) is positioned 1.0mm forward from an edge-to-edge position, while the upper tray (U) and the second lower tray (L2) have an additional 2.0mm protrusion. The user can select between the two positions as needed.

Therefore, the maximum protrusion is +3mm from edge to edge while using L2.

There are no variants for this device and it is available only in one configuration.

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The Lifestyles® HydraFeel Natural Rubber Latex Condom is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The LifeStyles® HydraFeel Natural Rubber Latex Condom is a single use condom made of natural rubber latex, featuring a straight-shaft, smooth-walled membrane that closely fits the penis. It acts as an barrier to prevent the transmission of sperm, bodily fluids, or STIs into the reproductive tract. The condom is coated with an aqueous lubricant and includes an integral bead at the open end for retention and a reservoir tip at the closed end to contain semen. The LifeStyles® HydraFeel Natural Rubber Latex Condom has a nominal length of 180 mm, width of 52 mm, and thickness of 0.045 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The device conforms with all sections of consensus standards ISO 4074:2015, Natural rubber latex male condoms – Requirements and test methods, and ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms).

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The AIO Breathe is intended to reduce snoring and to treat mild and moderate obstructive sleep apnea in children 6-17 years of age who are diagnosed with snoring and/or mild or moderate obstructive sleep apnea.

AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth. The device is manufactured at AIOMEGA facilities using additive manufacturing with Stereolithography (SLA) 3D printing technology that builds the device from biocompatible resins. The customized trays are fabricated based on intraoral scans provided by the dentist and the dentist's prescription.

AIO Breathe features right and left protrusive flanges on the buccal sides of the upper tray. These flanges engage with corresponding right and left vertical flanges featured on the buccal sides of the lower tray. This engagement repositions the jaw to reflect the dentist's prescribed anterior mandibular advancement.

Additionally, mandibular plateaus, as prescribed by the dentist, featured on the right, and left occlusal cranial surfaces of lower tray, guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw (jaw is not fixed in a single position) and work together to maintain advancement in open and closed mouth positions. This design feature allows more room and creates traction for the tongue to migrate forward. The resulting mechanical protrusion increases the patient's pharyngeal space, improving their ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.

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Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

Hospital size sterilizer cycles

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

Tabletop sterilizer cycles:

• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time

Ethylene Oxide sterilization cycles:

• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:

Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.

Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).

Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).

The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.

The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".

The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.

All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.

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The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies.

The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.

The Ceribell Headcap includes the following components:

• An elastic fabric headcap
• An elastic fabric chin strap
• Nine (9) silver/silver chloride (Ag/AgCl) electrodes
• A cable attached to the headcap to allow connection to an EEG acquisition/recording device

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The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

The LumiGuide system consists of the following primary devices:

The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.

The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The powder-free nitrile exam gloves are non-sterile, single-use, ambidextrous medical examination gloves made from nitrile butadiene rubber (NBR). They are blue, feature a beaded cuff, and are available in sizes S–XL. The gloves are not made with natural rubber latex.

Their physical and performance characteristics meet all requirements of ASTM D6319-19. The gloves are powder-free and meet the requirements of ASTM D6124-06. Powder is not used during any stage of manufacturing. Rather, the gloves are manufactured using a non-chlorinated polyurethane (PU) inner coating to reduce surface friction and facilitate donning. More specifically, following the dipping phase, the gloves pass through gelling and pre-curing ovens to stabilize the film and control thickness and tactile responsiveness. The PU coating is applied to the inner (donning) surface and then dried and cured, producing a smooth, low-friction finish. Residual processing aids are removed through rinsing/drying steps, resulting in a stable, non-reactive donning surface. Automated cuff beading is then performed to enhance edge durability and ease of application.

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G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

G-BLOCK is a compact block made of graphene-doped polymer suitable for the manufacture of dental prostheses using CAD/CAM technology. The polymer is based on polymethyl methacrylate (PMMA) doped with graphene (an allotrope of carbon).

G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.

G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.

G-BLOCK presents high modulus and elastic limit to ensure that the tensions generated during biting and chewing do not cause permanent deformations, and it is possible to manufacture prosthesis of smaller sections.

G-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.

G-BLOCK is low density making the prosthesis lightweight.

G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.

G-BLOCK has colour stability.

G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.

G-BLOCK is chemically inert.

G-BLOCK water absorption is 4 μg/mm³ and a solubility of 0.5 μg/mm². The release of residual monomer is minimum, with a percentage of 0.004% of residual monomer. Thanks to these physical properties G-BLOCK offers a durable and safety treatment.

G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.

The device is presented in the form of a polymer block glued to an aluminum pin that allows the device to be fixed on the milling machine so that the block can be milled to obtain dental prostheses with the use of specific CAD/CAM equipment.

G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.

When machined, Monochroma and Multichroma present a different visual effect:

• Monochroma, is made of a pure colour matching the dentin.

• Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.

Both variants are presented in two sizes: 14 and 40.

G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).

G-BLOCK are provided non-sterile and as a single use device.

G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.

G-BLOCK should be stored at room temperature in its original packaging, in dry storage and avoid exposure to direct sunlight. PMMA polymer from which the G-BLOCK is made is stable and can be stored for an extended period of 5-year shelf life.

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The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

The Edwards MC3 Tricuspid annuloplasty ring, model 4900, consists of two primary components: the implantable annuloplasty ring and the template/ lanyard assembly (or holder). The implantable annuloplasty ring is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.

The Edwards MC3 Tricuspid annuloplasty ring can be used in tricuspid valve repairs. The oval tricuspid ring conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. The annuloplasty ring is provided on an integral template which holds the ring during the plication to the annulus. A feature of the Edwards MC3 Tricuspid annuloplasty ring is that the rigid template is designed not to interfere with the tying of sutures and contains a retrieval system during the removal process. After implantation, this rigid template is removed.

The model 1150 handle may be utilized to facilitate ease of suture placement and annuloplasty ring implantation. The snap-fit assembly of the handle and template/lanyard assembly allows for connecting and disconnecting of the two components.

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