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Polyglycolic Acid-Caprolactone Suture Material Seraflex®
DESCRIPTION
SERAFLEX® is a natural, nonabsorbable, sterile surgical suture material derived from the cocoon fibres of the silkworm moth (Bombyx mori L.). The starting material, the raw silk fibre, consists mostly of the proteins fibroin and sericin.
In the manufacture of SERAFLEX® the raw silk fibre is degummed, i.e. freed of sericin, and braided. SERAFLEX® is a braided, silicone-coated suture and is available dyed black with Logwood black (haematin), Colour Index No. 75290 or undyed. SERAFLEX® in the cassette pack is supplied in an isopropanol-containing preserving solution.
Our silk suture materials are supplied in combinations with stainless steel needles or without needles. They satisfy the essential requirements of Directive 93/42/EEC on medical devices and the current edition of the harmonized standard of the European Pharmacopoeia (EP) for “sutures, sterile non-absorbable (fila non resorbilia sterilia)”or of the monograph “Nonabsorbable surgical suture” of the United States Pharmacopeia (USP). In deviation from this standard, the maximum thread length in the case of the cassette packs is not 3.5 but 100 m
COMPOSITION
Our silk suture materials should not be used in persons known to be allergic to silk. They are not intended for use in the central vascular or nervous systems. Because of the loss of tensile strength that may occur in the body, silk suture materials should not be used when prolonged stability of the thread is required.
INDICATIONS
Our silk suture materials are suitable for all wound sutures and ligatures in which nonabsorbable thread material is indicated with the exception of use in the central vascular or nervous systems. Silk threads can also be used as holding sutures and for marking purposes
PRESENTATION
Our silk suture materials are supplied in various gauge sizes, lengths, and colours and with various types of needle or without needles. The threads and combinations are supplied in nindividual packs and multiple packs in a sterile package. Economical cassette packs are vailable for bulk purchasers. More precise details are given in the catalogue.
MANUFACTURER
Serag-Wiessner GmbH & Co. KG
Zum Kugelfang 8 – 12
95119 Naila, Germany