DemeLON™(NYLON) Monofilament (Non-absorbable)

Description:

Suture Material

DemeTECH Nonabsorbable Nylon Suture is a nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6.

The monofilament or multifilament polyamide sutures with attached needles are available in black and blue dyed with FDA listed dye (s).

 Attached needles types offered include curved and straight needles, with several lengths, gauges and needle shapes and several suture lengths.

DemeTECH Nonabsorbable Nylon Suture meets all requirements established by the United States Pharmacopeia for nonabsorbable polyamide surgical sutures.

Intended use

The DemeTECH Nonabsorbable Nylon 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 Nonabsorbable Nylon Suture elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While it is not absorbed, progressive hydrolysis of the nylon in vivo may result in gradual loss of up to 20% of its tensile strength per year.

The DemeTECH Nonabsorbable Nylon Suture is available in various sizes; it may be monofilament or multifilament in form. The suture is supplied sterile in pre-cut lengths both non-needled and affixed to various needle types, in boxes of one dozen.

Characteristics

DemeTech’s Nylon suture is a non-absorbable, sterile surgical suture composed of the long chain aliphatic polymer Nylon 6.6.

This process is usually followed by gradual encapsulation of the suture by fibrous connective tissue.

- Composed of tightly braided filaments 

- Easy passage through tissues due to its low frictional coefficient. 

- Minimal tissue reactivity 

- Coated to improve handling. 

- Excellent elasticity 

- Exceptional for skin closures.

Indications

Warnings

• Do not resterilize. Discard open, unused sutures.

• 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 Nonabsorbable Nylon Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.

• As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, 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

When 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.

 As with any suture material, 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, gradual loss of tensile strength over time, 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.

Contraindications

Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, The DemeTECH Nonabsorbable Nylon Suture should not be used where permanent retention of tensile strength is required, as in fixation of intraocular lenses or synthetic vascular grafts.

Delivery Form

The DemeTECH Nonabsorbable Nylon Suture is available in various sizes; it may be monofilament or multifilament in form.

The suture is supplied sterile in pre-cut lengths both non-needled and affixed to various needle types, in boxes of one dozen.

More information: https://www.demetech.us/product/sutures/NylonMonofilament