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Polyglycolic Acid-Caprolactone Suture Material Serapren®
DESCRIPTION
SERAPREN® is a synthetic, monofilament, nonabsorbable, sterile surgical suture. The raw material for the suture is composed of isotactic polypropylene with the empirical formula [C3H6]n. SERAPREN ® blue is dyed with phthalocyanine blue, Colour Index Nr. 74160 or Solvent Blue, Colour Index No. 61568.
Propylene sutures are available in combination with swaged high-grade stainless steel needles. They are also available in different variations with special accessories for intracuticular suturing. The suture material satisfies the essential requirements of the Medical Device Directive 93/42/EEC and apart from marginally deviations with respect to the diameter (suture material < EP 1) the harmonised standard of the European Pharmacopoeia “Sterile nonabsorbable sutures (fila non resorbilia sterilia)”, and of the monograph “Nonabsorbable surgical suture” of the latest edition of the United States Pharmacopoeia (USP).
INDICATIONS
SERAPREN® is indicated for use in soft-tissue approximation and/or for ligation in cases where nonabsorbable suture material is indicated, including use in cardiovascular and neurological procedures as well as in microsurgery and ophthalmic procedures. Polypropylene sutures can also be used as stay sutures and for tagging.
PRESENTATION
SERAPREN® is available in a variety of strengths and lengths in the form of needle-suture combinations attached to various needle types. Pledgets to reinforce the body’s own structures may be enclosed with SERAPREN®. The combinations are supplied sterile in single and multiple packs (multipack). The intracuticular suture is provided together with special accessories. Please see catalogue for precise details.
MANUFACTURER
Serag-Wiessner GmbH & Co. KG
Zum Kugelfang 8 – 12
95119 Naila, Germany