PT154013F13M: 4-0 DemeTECH DemeDAC Polyester Braided (w/o Covering) white 18" P-3 Reverse Cutting - Braided, Non-Absorbable, Suture, Synthetic

In-Date » DemeTECH Suture » Polyester

DemeTECH DemeDAC™ Uncoated Polyester

(Braided without covering) (PT)

Suture Material

DemeTECH Polyester Non-absorbable Suture is a non-absorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, long-chain linear polyester having recurrent aromatic rings as an integral component. The sutures with attached needles meet FDA requirements for exempt color additives for polyester sutures. The product is available in several suture lengths and attached needle types. DemeTECH Polyester Non-absorbable Suture meets all requirements established by the United States Pharmacopeia (USP) for Non-absorbable Surgical Sutures.

INTENDED USE

The DemeTECH Nonabsorbable Polyester Suture with and without needles is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures. Product is intended for long term use over 30 days.

ACTIONS

The DemeTECH Polyester Nonabsorbable Suture elicits a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. DemeTECH Polyester Nonabsorbable Suture is not absorbed, nor is any significant change in tensile strength retention known to occur in vivo.

Characteristics

DemeTech’s Polyester (braided without covering) suture is a non-absorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). DemeTech’s Polyester (braided without covering) suture elicits a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture. High quality materials, combined with precise braiding mechanisms, nearly eliminate the occurrence of postoperative suture fragments in the tissue. - As Polyester (braided without covering) is not coated, it allows for extreme ease of use and secure knot tying. - It provides for minimal breakage, and thus eliminates the need to remove irritating suture fragments postoperatively. - As Polyester (braided without covering) is uncoated, it maintains a higher coefficient of friction as it passes through the tissue.

WARNINGS:

Do not resterilize. Discard open, unused sutures. • As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary of biliary tracts, may result in calculus formation. • Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing the DemeTECH Polyester Nonabsorbable Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. • Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds. • Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.

PRECAUTIONS

In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include: wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, enhanced bacterial infectivity, minimal acute inflammatory tissue reaction, pain, edema, and erythema at the wound site.

DemeTECH Corporation is a world-renowned leader in surgical sutures, mesh and bone wax. DemeTECH strives to enhance doctor-patient relationships through hard work, dedication, and a commitment to the pursuit of cutting-edge technology and innovation.

DemeTECH's quality has been proven time and time again: high demand and use worldwide, distribution in over 100 countries worldwide, and certification of the three major medical authorities: FDA, CE, and ISO

Through its incredible commitment to efficiency, DemeTECH is able to provide sutures of paramount quality at a lower and more reasonable cost. Thus, with a prosperous future ahead, DemeTECH sees no boundaries to its success and wishes to include you in this flourishing voyage.