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510(k) Data Aggregation
K Number
K152476Device Name
Exofin High Viscosity Tissue Adhesive
Manufacturer
CHEMENCE MEDICAL PRODUCTS INC.
Date Cleared
2016-02-09
(162 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
CHEMENCE MEDICAL PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K101276Device Name
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404
Manufacturer
CHEMENCE MEDICAL PRODUCTS INC.
Date Cleared
2010-07-28
(83 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
CHEMENCE MEDICAL PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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, including punctures 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.
Device Description
derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile. liquid topical skin adhesive containing a monomeric (2-octy) 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 also containing 2 Indothene HD Grade HD50MA180 applicator tips. The dauber applicator is comprised of a selfpuncturing 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 skin, the liquid is syrup-like in viscosity and polymerizes within minutes. derma+flex® QS™ High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity 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.
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