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  3. DRAIN, PENROSE, TUBULAR, sterile, Ø 1cm, min. 22 cm
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DRAIN, PENROSE, TUBULAR, sterile, Ø 1cm, min. 22 cm

https://unicat.msf.org/cat/product/18302
STD SCTDDRAP1--

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.
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.
A0601010402 - Cylindrical or circular drainages (straight and t-shaped)
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.
IIa
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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DRAIN, PENROSE, TUBULAR

Definition

A sterile device designed to establish a passive exit for the removal of fluid (drainage of blood, lymph, other fluids) from a surgical wound to minimize its accumulation and risk of infection. It is typically inserted into the wound by a surgeon in the operating room after the completion of a procedure.

Specifications

Quality standards

ISO 20697, 2018, edition 1, (confirmed 2023) Sterile drainage catheters and accessory devices for single use

Technical specifications

  • Material: latex (allergie is possible), silicone coated latex or silicone
  • Flat, thin, very soft tube
  • Sterile, for single use
  • Size of the drain varies according to the manufacturer.
    • Diameter: 10 mm
    • Length: 22 (minimal) to 50 cm

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

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