Device Dossier

GEM Microsuture - Nylon suture, monofilament

Device Dossier for GEM Microsuture - Nylon suture, monofilament (Nylon suture, monofilament, Class III, sponsor Microsurgical Specialties). ARTG record,…

Intended purpose

Indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological surgery.

Functional description

Nylon monofilament sutures are inert, non-absorbable, sterile sutures composed of long-chain aliphatic polymers Nylon 6 and Nylon 6.6.The sutures are dyed black & meet USP requirements. Sutures elicit a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the sutures by fibrous connective tissue. Progressive hydrolysis of the suture, in vivo, may result in gradual loss of tensile strength over time. CobraBlack needles enhance visibility & eliminate glare.

TGA Public Summary