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SUT. NON ABS. mono (2/0) needle 3/8 30mm rev. cutting

https://unicat.msf.org/cat/product/19138
STD SSUTSNAM20R1

Valid Article

Former Code(s): SSUTSNAM3CT SSUTSNAM20C1
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
H01020101 - Monofilament non-absorbable synthetic sutures
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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NON ABSORBABLE SUTURE, synthetic, monofilament

The brand names are given for information only. A specific brand of suture may be purchased after validation of the quality dossier.

  • Ethicon : Ethilon, Prolene
  • BBraun : Dafilon, Premilene
  • Peters surgical : Filepeau, Nylon, Polypropylen
  • Covidien : Dermalon, Monosof, Surgipro
  • Teleflex : Nylon

Definition

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) or polypropylene (PP), intended to join the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it includes an attached needle. The thread provides temporary wound support until the wound sufficiently heals. It can be removed from the tissue once the wound has healed, or remain in situ where it is gradually encapsulated by fibrous connective tissue. This is a single-use device intended to be used in a sterile condition.

Specifications

Quality Standards Comment

European Pharmacopoeia: Ph. Eur. Monograph 0324

USP: Non-absorbable surgical suture

Technical specifications

  • Non-absorbable suture, monofilament, synthetic
  • Uniform cylindrical diameter
  • Tissue reaction is minimal
  • Not coated
  • Providing excellent knot security
  • Smooth passage through tissue, avoiding tissue drag
  • Shelf life = 5 years
  • Length: +/- 75 cm

Suture material: polyamide (PA) = nylon

  • Presented in blue (most common) or green (avoid black sutures)
  • Obtained from extrusion of polyamide (6.0 and 6.6)
  • Nylon is a non-absorbable material that with time becomes encapsulated by connective tissue.
  • It is known that the thread mass diminishes, approximately by 10% a year due to the rupture of chemical links in the thread as a result of hydrolytic action
  • Sterilization: EtO or gamma radiation

Suture material: polypropylene = PP

  • Presented in a blue colour
  • Extraordinarily stable; ideal for fulfilling its purpose for permanent tissue support without compromising its tensile strength
  • Low tissue reaction, ideal biocompatibility
  • Sterilization: EtO

diameter (mm)

metric size

EP designation

USP designation
0.4 mm41
0.35 mm3.50
0.3 mm32-0 or 2/0
0.2 mm23-0 or 3/0
0.15 mm1.54-0 or 4/0
0.1 mm15-0 or 5/0
0.07 mm0.76-0 or 6/0

Labelling

The details strictly necessary for the user to identify the product properly are indicated on or in each sachet (primary packaging) and on the protective cover (box) and include at least:

  • name of the product and intended use (surgical non-absorbable suture)
  • thread: gauge number, length (cm), structure (monofilament)
  • needle: length (mm), curve (X/8) and point

Packaging & Labelling

double packaging of each suture:

  • outer packaging: good peelability is decisive for easy opening and contamination-free transfer by a non-sterile person
  • inner packaging of laminated film with aluminium coating provides additional protection for the suture and allows safe and easy removal

Instructions for use

All sutures are sterile articles, and for single use only.

For more information see introduction: General information about sutures.

INDICATIONS SEE TABLE BELOW

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Extra Tables

MSF code

THREAD FIL

NEEDLE : 

surgical steelAIGUILLE: acier chirugical

USE

UTILISATION
 

Gauge

Type

Curve‌ Courbe

Size‌ Taille

SSUTSNAM60T2

6/0

Double needle, taper

3/8

10 mm

Vascular surgery

Chirurgie vasculaire

SSUTSNAM50T1

5/0

Taper

1/2

13 mm

Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardio-vascular surgery, ophthalmic and neurological procedures

La suture est indiquée pour une utilisation dans approximation générale des tissus mous et / ou ligature, y compris l'utilisation en chirurgie cardio-vasculaire, les procédures ophtalmiques et neurologiques

SSUTSNAM50T2

5/0

Double needle

Taper

3/8

13 mm

SSUTSNAM40T2

4/0

Double needle

taper

3/8

17 mm

Vascular surgery –vascular anastomosis

Chirurgie vasculaire, anastomose vasculaire

SSUTSNAM30R1

3/0

 Reverse cutting

3/8

18 mm

Fibrose and dense tissue approximation

skin suture, intradermal suture

Rapprochement de tissu fibreux et dense,
suture de la peau,
suture intradermique

SSUTSNAM30T1

3/0

Taper

1/2

18 mm

Fibrose and dense tissue approximation (i.e : tendon repair)

Approchement de tissu fibreux et dense (la réparation des tendons)

SSUTSNAM20R1

2/0

Reverse cutting

3/8

30 mm

Soft tissue approximating (i.e : skin suture)

Approchement des tissus mous (suture de la peau)

SSUTSNAM1T1

1

Taper

1/2

30 mm

Soft tissue approximating (i.e : repair inguinal hernia)

Approchement des tissus mous (réparation d’une hernie inguinale)