Search Results

Kerecis® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Kerecis® Tendon Protect is a medical device made from solid fish skin (North Atlantic Cod) sheets of thickness no less than 0.4 mm. The product is intended to provide a covering around the newly repaired tendon for the management and protection of tendon injuries in which there has been no substantial loss of tissue. The device with natural structure and proteins from fish skin is applied around the newly repaired tendon. The structure of the fish skin provides a supportive environment for new host tissue deposition as part of wound healing while still providing an initial barrier facilitating the sliding of the repaired tendon within the surrounding tissue during tendon use. The biomechanical strength for the tendon itself is provided separately by sutures used to repair the tendon tear and/or by sutures or bone anchors used to attach the tendon tissue to the bone. The fish skin is fully integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The device is biocompatible, non-crosslinked, bioresorbable, strong, and pliable. Its tensile strength supports fixation by sutures customary for tendon protection surgical procedures. The device is intended for one-time use and supplied sterile in labelled Tyvek® pouch packaging. The subject device is available in following sizes: - 3x5 cm size - 6x9 cm size Kerecis® Tendon Protect is a standalone, single use medical device made from fish skin that is technologically similar to the predicate device Tendon Wrap Tendon Protector (K053655) (Substantial Equivalence) and identical to the Kerecis® Reconstruct™ (K202430).

Management of wounds including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, partial thickness burns, skin tears) - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Draining wounds

Kerecis "Parvus™ is a lyophilized, terminally sterilized, acellular, particulate fish skin medical device comprised of biocompatible, non-crosslinked, resorbable, acellular fish skin (North Atlantic Cod) for wound management. The device is intended for single use only. The subject device is packaged in the following weights: 100mg (4 cm2) 200mg (8 cm2) 500mg (19 cm²) 1000mg (38 cm²) 2,500mg (95 cm2 ) 3,000mg (114 cm2)

Kerecis Silicone is indicated for the management of wounds including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears) - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Draining Wounds

The subject device is a bilayer of processed resorbable acellular fish dermal matrix adhered to a thin, transparent, porous, soft silicone layer. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process. The fish dermal matrix layer is approximately 1 mm in thickness and is porous. The silicone layer is a transparent polyurethane film single-coated with soft, medical grade silicone that is attached to the scaly side of the fish dermal matrix. The silicone layer is porous, soft and conformable to the wound surface. The subject device is supplied as a sterile intact sheet offered in two configurations: a) with the silicone layer extending beyond the borders of the fish dermal matrix and b) the silicone layer having the same dimension as the fish dermal matrix with no silicone layer extending beyond the fish dermal matrix. The silicone acts as: protection for the fish dermal matrix layer, as additional wound coverage, and in configuration (a), as an adhesive contact layer to the skin surrounding the wound. The silicone layer can be peeled off as the fish dermal matrix is resorbed. The device is intended for single use only.

The subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

The subject device is a fish skin medical device indicated for physical reinforcement of a soft tissue defect or weakness. The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular solid sizes: 4x7 cm, 7x10 cm, 7x20 cm. The subject device is biocompatible, non-crosslinked, and therefore resorbable, strong, flexible, and supports fixation.

Kerecis Gingiva Graft is indicated for: - Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.

The subject device is fish skin medical device indicated gingiva augmentation. The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes: - 15mm x 20mm - 20mm x 30mm - 30mm x 40mm The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue. The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.

MariGen Wound Extra is indicated for the management of wounds, including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Trauma wounds (second degree burn, abrasions, lacerations, skin tears), - Surgical wounds (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), - Draining wounds.

The subject device is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in sizes up to 20 x 30 cm. The subject device is obtained from fish skin via standardized controlled GMP manufacturing process and supplied in terminally sterile packaging. The subject device is biocompatible, pliable, and non-cross linked. The device is intended for single use only.

Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers. Kerecis SecureMesh can be used for reinforcement of staple lines during: - Bariatric surgical procedures - Colorectal and Colon surgical procedures - Gastric, small bowels and mesentery procedures - Lung and bronchus resections

Subject Device is formed of intact acellular fish skin and is intended to be used as a staple line buttress with surgical staplers. The buttress material is supplied in a double pouch sterile packaging (EtO), where a pair of buttresses is provided on a pair of carriers to be used by a healthcare professional, to transfer the buttresses to the opposed jaws of a surgical stapler in the operating theatre prior to a stapling procedure. One pair of carrier and a buttress is used for each stapler firing.

MariGen Wound is indicated for the management of wounds including: - . Partial and full-thickness wounds - . Pressure ulcers - . Venous ulcers - . Chronic vascular ulcers - . Diabetic ulcers - . Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) - . Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence). - . Draining wounds

The Kerecis MariGen Wound Dressing is processed fish dermal matrix composed of fish collagen and is supplied as a sterile intact, or meshed sheet ranging in size from 3 x 3.5 cm (10.5 cm2), 3 x 7 cm (21 cm2) and 7 x 10 cm (70 cm2). The device is intended for a single patient, one time use only.