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SUT. ABS. mono PDO (2/0), needle 1/2, 35 mm taper

https://unicat.msf.org/cat/product/66044
STD SSUTSAMD20T1

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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.
H010101010101 - Polydioxanone monofilament with needle for open surgery
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.
III
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT30
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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ABSORBABLE SUTURE, monofilament, polydioxanone

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

  • Ethicon : PDS II
  • BBraun : MonoPlus
  • Peters surgical : Monotime
  • Assut: AssuCryl MonoSlow
  • Teleflex : Monodek

Definition

A single-strand (monofilament), synthetic, bioabsorbable thread made from polydioxanone (PDS), intended to join the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides long term temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. It includes an attached disposable needle. This is a single-use device intended to be used in a sterile condition.​

Specifications

Quality Standards Comment

European Pharmacopoeia: Ph. Eur. Monograph 0667

USP : absorbable surgical suture

Technical specifications

  • Material: poly (p-dioxanone):
  • Absorption complete by 180 – 210 days
  • Tensile strength
    • 75-80% @ 2 weeks
    • 65 – 70% @ 4 weeks
    • 55 – 60% @ 6 weeks (for 3/0 and larger)
  • Mono filament, synthetic, absorbable suture
  • Uniform cylindrical diameter.
  • Tissue reaction is minimal during the absorption process
  • Not coated
  • Pliable and easy to knot
  • High knot tensile strength
  • Smooth passage through tissue, avoiding tissue drag
  • Shelf life = 5 years
  • Length: +/- 75 cm
  • Colour: violet

diameter (mm)

metric size

EP designation

USP designation
0.4 mm41
0.3 mm32-0 or 2/0
0.15 mm1.54-0 or 4/0

INDICATIONS SEE TABLES BELOW

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 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.

Storage

Below 30°C

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Extra Tables

MSF code

THREAD

NEEDLE : 

surgical steelAIGUILLE : acier chirurgical

USE

UTILISATION

 FIL

type

Body

Corps

Curve

Courbe

Size

Taille

SSUTSAMD1T1

1

Taper

Round

4/8

40 mm

fascia closure in midline laparotomies to prevent incisional hernia

Fermeture du fascia pour des laparotomies afin d’éviter une hernie incisionnelle

SSUTSAMD20T1

2/0

Taper

Round

4/8

35 mm

SSUTSAMD40T1

4/0

Taper

Round

3/8

17 mm

For digestive anastomosis

Anastomose digestive