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The SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow by the occlusion of the canaliculus in order to: - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and - Determine the potential effectiveness of permanent occlusion.

The Oasis Medical SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug is a mid-term duration device designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from degradable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and have a base diameter of 0.6mm with one end tapered to enable easier placement through the punctal opening.

The Soft Plug® Extended Duration 180 Canalicular Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and - Determine the potential effectiveness of permanent occlusion.

The OASIS Medical SOFT PLUG® Extended Duration 180 Canalicular Plug is a mid-term implant designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from absorbable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and available in 0.2mm, 0.3mm, 0.4mm, and 0.5mm diameters.

Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths. The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths. Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.

The OASIS N-PE Microkeratome Blades are designed as replacement blades for the Nidek MK-2000 Microkeratome for lamellar resection of the comea.

The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 series low carbon stainless steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.

The OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.

The OASIS Disposable M2-PE Microkeratome Blades are replacement stainless steel blades for the Moria M2 Microkeratome Blade. The Disposable M2-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable M2-PE Microkeratome Blades are single-use, disposable blades.

The OASIS Disposable N-PE (Precision Edge) Microkeratome Blade (Catalog #0412) is a replacement blade for the Nidek MK-2000 Microkeratome for lamellar resection of the cornea.

The OASIS Disposable N-PE Microkeratome Blades are replacement stainless steel blades for the Nidek MK-2000 Microkeratome blade. The Disposable N-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable N-PE Microkeratome Blades are single-use, disposable blades.

The OASIS Medical Soft Plug® Absorbable Plug - SA is intended for temporary use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blockage of the canaliculus. It may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, the OASIS Medical Soft Plug® Absorbable Plug - SA may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye.

The proposed device, the Soft Plug® Absorbable Plugs - SA, is substantially equivalent in intended use and operation to the various collagen intracanalicular plugs in the market today. These include the Soft Plug Collagen Intracanalicular Plug by OASIS Medical (K946357), the Temporary Intracanalicular Plug by Eagle Vision (K890919), and the Collagen Implants For Use in the Lacrimal Efficiency Test™ by Lacrimedics (K895342). All of these plugs are 2 mm long and are cut from non-sterile suture material. The implants are intended to be inserted into the canaliculus to block fluid flow for a temporary period of time (less than 3 months based on results obtained in an animal study) until they are absorbed. The only difference is the type of absorbable suture they are cut from, polyglyconate versus collagen, and the length of time they will take to absorb, less than 3 months versus several days. The proposed device, the Soft Plug® Absorbable Plugs - SA, is also similar in intended use and operation to the Herrick Lacrimal Plug™ by Lacrimedics (K896175). This is a silicone intracanalicular plug intended for insertion into the canaliculus to permanently block fluid flow. It approximates the size of the absorbable plugs mentioned above.