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SUT. ABS. braided (2/0) SPOOL w/o needle

https://unicat.msf.org/cat/product/19124
STD SSUTSABB20-

Valid Article

Former Code(s): -X SSUTSABB3--
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.
H010101020203 - Polyglycolic with lactic acid multifilament without needle
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
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, synthetic & braided

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

  • Ethicon: Vicryl
  • BBraun : Safil, Novosyn
  • Peters surgical : Optime
  • Assut: AssuCryl, Assucryl Lactin
  • Covidien : Dexon, Polysorb

Definition

A multiple-strand (multifilament), synthetic, bioabsorbable thread made from polygalactine or polyglycolide, usually coated, intended to join the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include 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

  • Absorbable cylindrical multifilament and braided thread
  • Polyglycolid (PGA) or polyglactin 910 (PGLA)
  • Coated to improve smoothness and reduce tissue drag and capillarity. (polycaprolactone or polygalactin and calcium stearate)
  • Violet or undyed (important feature for plastic surgery, for intradermal continuous suture)
  • Tensile strength: 50% remains 3 weeks post implantation
  • Predictable absorption through hydrolysis, complete by 60 to 90 days
  • Excellent knot coupling
  • Sterilization by Ethylene Oxide
  • Shelf life: 5 years
  • Length: +/- 75 cm

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

Labeling

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 (braided)
  • 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

Precautions for Use

Caution must be taken when used in elderly, malnourished or immunologically deficient patients, in which case the critical cicatrization period of the wound may be delayed.

Since it is an absorbable suture, it should not be used where extended tissue support is needed for an indefinite period of time.

Storage

Below 30°C

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Extra Tables

MSF code

THREAD

FIL

NEEDLE : surgical steel

 AIGUILLE : acier chirurgical 

USE

UTILISATION

 

gauge

Point

Pointe

Body

Corps

Curve

Courbe

Size

Taille

SSUTSABB30T1

3/0

taper

round

3/8

18 mm

Soft tissue approximation and/or ligation (i.e. : digestive and  urology surgery, vascular surgery, subcutaneous tissues approximation)

Rapprochement et / ou la ligature des tissus mous (par exemple: chirurgie digestive et l'urologie, la chirurgie vasculaire, rapprochement des tissus sous-cutanés)

SSUTSABB20-

2/0

spool

spoolspoolspool

haemostasis

hémostase

SSUTSABB20R1

2/0

reverse cutting

triang

3/8

24 mm

Patients don’t have to come back for removing stitches

Les patients ne doivent pas revenir pour enlever les points de suture.

SSUTSABB20T1

2/0

taper

round

1/2

30 mm

Soft tissue approximation and/or ligation (i.e. : digestive and  urology surgery, vascular surgery, subcutaneous tissues approximation)

Rapprochement et / ou la ligature des tissus mous (par exemple: chirurgie digestive et l'urologie, la chirurgie vasculaire, rapprochement des tissus sous-cutanés)

SSUTSABB0--

0

spool

spoolspoolspool

haemostasis

hémostase

SSUTSABB0T1

0

taper

round

1/2

31 mm

General use (gynaecology)

Soft tissue approximation

Usage général (gynécologie)

rapprochement des tissus mous

SSUTSABB1T1

1

taper

round

1/2

40 mm

Soft tissue approximation and/or ligation (i.e. : digestive and  urology surgery, abdominal wall approximation)

Rapprochement et / ou la ligature des tissus mous (par exemple: chirurgie digestive et l'urologie, le rapprochement de la paroi abdominale)

SSUTSABB1T2

1

taper

round

3/8

50 mm

Parenchyma

Parenchyme

SSUTSABB1T3

1

taper

round

3/8

65 mm

B-Lynch compression suture: to mechanically compress an atonic uterus in case of severe PPH

Suture compressive B-Lynch: compression mécanique en cas d’atonie utérine et PPH sévère

SSUTSABB20B1

2/0

protection

round

1/2

35 mm

Reserved for contexts with highly contagious infectious diseases

Réservé aux contextes de maladies infectieuses hautement contagieuses

SSUTSABB0B1

0

protection

round

1/2

35 mm

Reserved for contexts with highly contagious infectious diseases