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PLOYESTER COATED BRAIDED

General Information

DESCRIPTION

Polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high molecular weight, long-chain,linear polyesters having recurrent aromatic rings as an integral component. Polyester sutures are braided for optimal handling properties, and for good visibility in the surgical field, are dyed green.

INDICATIONS

Polyester  suture is indicated for use in general soft tissue approximation and/or ligation,including use in cardiovascular, ophthalmic and neurological procedures.

ACTIONS

Polyester  suture elicits a minimal acute inflammatory reaction in tissue, followed by a gradual encapsulation of the suture by fibrous connective tissue. Implantation studies in animals show no meaningful decline in polyester suture strength over time. The polyester fiber suture material is pharmacologically inactive.

CONTRAINDICATIONS

None known.

WARNINGS

Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Ployester suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.Do not resterilize. Discard opened packages and unused sutures.As with any foreign body, prolonged contact of any suture with salt solutions, such as thosefound in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds.

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. The use of additional throws is particularly appropriate when knotting monofilament sutures.As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehiscence, calcul information in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens.

HOW SUPPLIED

Polyester sutures are available as sterile, braided, green and undyed (white) strands in sizes 6-0 through 5 (metric sizes 0.7-7) in a variety of lengths, with and without permanently attached needles.Polyester  sutures are also available in green monofilament in U.S.P. sizes 10-0 and 11-0(metric sizes 0.2-0.1).Polyester sutures, green, braided in U.S.P. size 0 (metric size 3.5)are also available attached to CONTROL RELEASE removable needles.Polyester  sutures are available in one, two and three dozen boxes.

Figures In U.S.P Standard:

Size Diameter(mm)  Knot-Pull Strenght (kgf)    Needle Attachment (kgf)
U.S.P Metric  Min Max Average Min   Individual Min Individual  Min
 7/0  0.5
0.050
  0.069
         0.11
0.080 0.040
6/0#  0.7
0.070
  0.099
         0.20
0.17 0.008
5/0#

      1

0.10
  0.149  
        0.40      
0.23  0.11
4/0# 1.5
0.15
  0.199
        0.60
0.45 0.23
3/0# 2
0.20
  0.249
        0.96       
0.68 0.34
2/0# 3
0.30
  0.339
       1.44       
1.10 0.45
0# 3.5
0.35
  0.399
       2.16
1.50 0.45
1#  4
0.40
  0.499
       2.72
1.80 0.60
2#  5
0.50
  0.599
       3.52
1.80 0.70
3#&4#   6
0.60
  0.699
       4.88
1.80 0.70

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