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CUTIVA™ Topical Skin Adhesive (RM1700) is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. CUTIVA™ Topical Skin Adhesive (RM1700) should be used in conjunction with, but not in place of, deep dermal stitches. The CUTIVA™ PLUS Skin Closure System (RM1739) is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CUTIVA™ PLUS Skin Closure System (RM1739) should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the application of the liquid adhesive.

CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) are skin closure devices that are comprised of a 2-octyl cyanoacrylate liquid adhesive formulation. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. The CUTIVA™ PLUS Skin Closure System (RM1739) also incorporates a self-adhering mesh component that is applied to the wound prior to the application of the liquid adhesive to align the skin edges. The liquid adhesive is then applied to the mesh with the adhesive applicator to complete the device application. Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) provide a physical barrier to microbial penetration as long as the adhesive film remains intact. In vitro studies have been performed to demonstrate the microbial barrier properties of CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) for 72 hours after device application. No clinical studies have been performed and no clinical benefit associated with the in vitro microbial barrier performance of the device has been demonstrated.

CM005 Standard Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff. CM004 Mini Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.

CM005 Standard Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes. CM004 Mini Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2 It is provided in a singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.

Exofin® Precision Pen is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® Precision Pen is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity assists in the unintended placement of the adhesive during application due to migration of the liguid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

Exofin® High Viscosity Topical Skin Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.

LiquiBand® Plus is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches.

LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes. In vitro studies have shown that LiquiBand® Plus topical skin adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.

derma+flex® QS ™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.

SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures

SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.

ACTABOND Topical Skin Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. ACTABOND Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

ACTABOND Topical Skin Adhesive is a skin closure device that is comprised of a 2-octyl cyanoacrylate liquid adhesive formulation containing D & C Violet #2. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. In vitro studies have shown that following application, ACTABOND Adhesive acts as a barrier to prevent bacterial penetration. The barrier properties of ACTABOND Adhesive have not been studied in clinical or animal models.

Exofin® High Viscosty Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Exofin® High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In vitro studies have shown that Exofin®High Viscosity Tissue Adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.