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  3. DRAIN, DELBET, CORRUGATED SHEET, sterile, min 3 cm x 25 cm
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DRAIN, DELBET, CORRUGATED SHEET, sterile, min 3 cm x 25 cm

https://unicat.msf.org/cat/product/18301
STD SCTDDRAD3--

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.
A0601010403 - Flat and lamellar drainages
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, DELBET, CORRUGATED SHEET

Definition

A sterile device designed as a flexible, undulated surface used to drain fluids or purulent material (e.g., blood, serum, pus, or urine) from the body. It has several channels through which fluid can move away from a site. It is mostly used during a surgical intervention where it is attached to the wound. It is available in various widths; large sheets may be cut into required size by the user.

Specifications

Quality standards

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

Technical specifications

  • Corrugated sheet
  • Natural rubber, synthetic elastomer or silicone
  • Size of drain depends according to manufacturer, minimum: 3 cm x 25 cm, bigger sizes are possible
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

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Precautions for Use

Allergy to latex is possible.

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