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SUT, ABS. rapid, braided (0) needle 1/2 40mm taper

https://unicat.msf.org/cat/product/19131
STD SSUTSABR0T1

Valid Article

Former Code(s): -X SSUTSABR3HR
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.
H010101020101 - Polyglycolic acid multifilament 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
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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RAPID 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 rapide
  • BBraun : Safil Quick, Novosyn Quick
  • Peters surgical: Optime rapide
  • Assut: AssuCryl Rapid
  • Covidien: Velosorb Fast

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. It dissolves in the body fluids and disappears quickly. 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

  • Absorbable cylindrical multifilament and braided thread
  • PGA or PGLA with a higher absorption rate: sutures “Rapid” “Fast” or “Quick”
  • Coated and undyed
  • Tensile strength 50% @ 5 - 7 days
  • Predictable absorption through hydrolysis, complete by 42 days
  • Excellent knot coupling
  • Sterilization by gamma radiation
  • Shelf life: 3 years
  • Length: +/- 75 cm

diameter (mm)

metric size

EP designation

USP designation
0.35 mm3.50
0.2 mm23-0 or 3/0

MSF code

THREAD​

NEEDLE : surgical steel

USE

Gauge

Type

Body

Curve

Size

SSUTSABR30C1

3/0 rapid

cutting

round

1/2

26 mm

Episiotomy, intradermal ​continuous suture

SSUTSABR0T1

0 rapid

taper

round

1/2

40 mm

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 (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.

Storage

Below 30°C

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