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The Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The Biodesign Otologic Butterfly Graft is a self-securing butterfly-style graft structure with the same underlay component as the predicate device, attached to an external stabilizing component with an absorbable knotted thread, all made from the same SIS (small intestinal submucosa) ECM material as that of the predicate device. This self-securing structure maintains the location and close tissue approximation of the underlay component across the tympanic membrane (TM) defect as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Cook® Biodesign® Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). SIS is obtained from the intestine using a process that retains the natural composition of matrix molecules such as collagen (Types I, III, VI), glycosaminoglycans (hyaluronic acid, chondroitin sulfate A and B, heparin, and heparin sulfate), proteoglycans, and fibronectin. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process. Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.

Adaptain" is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Adaptain™ is a water-soluble, wax-like surgical implant material that will adhere to itself utilized directly and a first application of firm pressure. Adaptain " is designed to be utilized directly out of the package. The implant will soften as it is warmed. The surface of the implant becomes lubricious when wet, and the implant does not swell as it dissolves. Adaptain™ is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™) and contains no other additives or colorants. Adaptain is supplied in a number of forms including bars, sticks, granules and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ is provided sterile by irradiation and must not be resterilized.

The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel™ Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication. The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

Adaptain FastWrap™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Adaptain FastWrap™ is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional . handling and manipulation, if so desired. Adaptain FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.

Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Adaptain™ Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.

Ceretene" Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Ceretene" Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ceretene" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC). Ceretene™ Soluble Implant Material contains no other additives or colorants. Ceretene" Soluble Implant Material is formed in bars and sheets of various weights ranging from 0.5 to 5 grams each. Ceretene" Soluble Implant Material is provided sterile by irradiation and must not be resterilized.

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal to moderate bleeding by tamponande effect, blood absorption and platelet aggregation.

The Gel-Sponge ENT is a sterile, absorbable gelatin sponge, USP available in sizes ranging from a 1.5 cm disk to a 100 cm rectangular size. It is able to absorb and hold within its interstices, many times its weight of blood and other fluids. The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. Hemostasis is achieved by the physiological coagulation-inducing properties of the absorbable gelatin sponge. USP, The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied dry or is wetted before use with sterile water for injection or saline (not provided),

AOC" -L is indicated for use as an aqueous water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

AOC" -L Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC" -L Soluble Implant Material contains no other additives or colorants. AOC" -L Soluble Implant Material is formed of various weights ranging from 0.5 to 5 grams each. AOC" -L Soluble Implant Material is provided sterile by irradiation and must not be resterilized.