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510(k) Data Aggregation
K Number
DEN130004Device Name
MOERAE SURGICAL MARKING PEN
Manufacturer
MOERAE MATRIX, INC.
Date Cleared
2014-12-18
(591 days)
Product Code
PDW
Regulation Number
878.4670Why did this record match?
Applicant Name (Manufacturer) :
MOERAE MATRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasoPrep Surgical Marking Pen is intended for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft.
Device Description
The VasoPrep Surgical Marking Pen is a single patient use sterile prescription use only marker intended for use on veins prior to or during Coronary-Assisted Bypass Graft (CABG) surgery. The marker (Figure 1) consists of a pen body, barrel, wick and cap with a wide chisel style applicator tip for delivery of ink to mark internal tissue. The formulation is non-toxic as used and is comprised of an ink material (FD&C Blue Dye #1) compounded into a carrier material (i.e., solvent). The wide chisel tip can deliver either a thin line of ink for precise marks or can be rotated 90° to deliver a wide stripe of ink.
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K Number
K131659Device Name
MOERAE VEIN PREPARATION KIT
Manufacturer
MOERAE MATRIX, INC.
Date Cleared
2014-03-03
(270 days)
Product Code
GBX
Regulation Number
878.4200Why did this record match?
Applicant Name (Manufacturer) :
MOERAE MATRIX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
Device Description
The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.
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