Dermalon™ Monofilament Nylon Sutures, 4-0, C-13 Needle

Structure

monofilament

Suture Type

non-absorbable

Composition

nylon

Coating

uncoated

Color

blue

Tensile Strength

gradual loss over time

Absorption Profile

permanent

Sizes

1 through 6–0 

Indications

Dermalon™ monofilament nylon suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

Contradictions

Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, nylon sutures should not be used where permanent retention of tensile strength is required.

Sterilization Method

ethylene oxide

CE Marked

class III according to EU directive 93/42/EEC, annex II

Box Quantities

1, 2 or 3 dozen

Shelf Life

5 years

Temperature and Humidity Levels

Currently, the IFU for Medtronic Legacy Covidien SI Suture devices state to store at room temperature. In general, stability studies are performed with short term exposure to either 50 degrees (38 weeks) or 54.4 degrees (32 weeks) for accelerated aging testing purposes only. This condition is not intended for storage purposes. Real time testing is performed at 22 degrees +/- 10 degrees with uncontrolled humidity for the entirety of the device shelf-life.