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Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for male patients only (adults and pediatric above the age of 1 years).

The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.

The ReTrace Ureteral Access Sheath is a sterile, single use device that is inserted over a guidewire into the upper or lower urinary tract of patients requiring ureteroscopic procedure sin a hospital environment. The ReTrace Ureteral Access Sheath consists of: - Reinforced tube/sheath - Introducer/dilator - Connector - Clip The reinforced polymeric introducer sheath includes a hydrophilic coating on the exterior and a lubricious inner surface. The sheath is reinforced to provide kink resistance. The distal tip of the sheath is fitted with a radiopaque ring. A white connector is fitted on the proximal end of the sheath and an orange connector is on the proximal end of the introducer to allow the two components to be attached. The dilator is fitted with a Luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and exit holes for fluid delivery are located at the distal end of the introducer. The dilator protrudes out the distal end and allows for a gradual enlargement of the passage if needed and improves trackability along the guidewire. Once in the desired location, the dilator is removed to establish a hollow conduit for insertion of endoscopes and other instruments into and out of the urinary tract. The ReTrace Ureteral Access Sheaths are available in two diameters 10/12 Fr and 12/14 Fr. Lengths range between 28 and 55 cm. This submission is for modifications to device materials, labeling, packaging, and connector design.

The product is indicated for use on moderate to highly exuding acute and chronic wounds such as: - · Diabetic ulcers - · Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology) - · Pressure injuries (stage 2-4) - Traumatic wounds - · Partial thickness (second degree) burns - · Donor sites - · Post-operative surgical wounds - · Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma

Biatain Fiber Ag is a soft, sterile, primary wound dressing made mainly from non-woven gelling carboxymethyl cellulose (CMC) fibers. In addition, non-gelling bicomponent (BiCo) fibers are incorporated to obtain strength and integrity of the products both in dry and gelled condition. Ionic silver (Ag+) is added for antimicrobial efficacy within the dressing, and ethyl lauroyl arginate (LAE) is added as combined surfactant and chelator within the dressing.

The catheter is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for male patients only.

The SpeediCath Flex Coudé catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a flexible bendable tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.

Restorelle M and XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.

NovaSilk Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

NovaSilk Mesh is an implantable, permanent, non-resorbable, synthetic support mesh manufactured from knitted, monofilament polypropylene. It is square in shape, measuring 150mm x 150mm, and 0.25mm thick.

Restorelle L Polypropylene Mesh is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.

SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The device is intended for females only.

The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.

The Coloplast Exair Anterior and Posterior Prolapse Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the implant is achieved. The system instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.

SpeediCath Compact is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The catheter is for female patients only.

SpeediCath Compact is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. The packaging of SpeediCath Compact is an integrated part of the product functioning partly as an insertion handle. In use, the inner tube is extended and removed from the handle as the catheter is locked in place with the handle. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.