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HAEMOSTATIC ABSORBABLE COMPRESS, dense O(R)C, 7x10cm, ster.

https://unicat.msf.org/cat/product/45121
STD SDREHACB2751

Valid Article

Former Code(s): SDREZBD0020
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.
M040501 - Polysaccharide haemostatic dressings
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 HEMOSTATIC DRESSING, O(R)C

Definition

Sterile, bioabsorbable device derived from plant polysaccharides (e.g., cellulose, starch, agar derivative) intended to be applied to surgical and traumatic wounds to facilitate local haemostasis primarily through denaturation of blood proteins and/or adherence to blood platelets. It is applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent.

Specifications

Cellulose is a homopolysaccharide produced by polymerization of glucopyranose through β-glucosidic bonds. Oxidized cellulose can be either regenerated (ORC, organized fibers are formed before oxidation) or non-regenerated (ONRC, with unorganized fibers prior to oxidation).

Oxidized cellulose is known for its ease of use, favorable biocompatibility, and bactericidal properties.

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Quality Standards Comment

USP Monographs: Oxidized Regenerated Cellulose

Technical specifications

  • material: ORC = oxidised regenerated cellulose or ONRC = oxidised non regenerated cellulose
  • fibers in a dense knitted mat
  • flexible and can be cut without fraying and folded to conform to irregular surfaces
  • does not stick to instruments
  • easy (re)positioning at the bleeding site
  • no memory effect
  • absorbable
  • sterile, for single use
  • size: 7 - 7.5 x 10 cm

Packaging & Labelling

Each dressing is packed in a disposable peel pack allowing effective sterilization, safe handling, and storage of all pouched items until needed for use and facilitating proper aseptic presentation of the material.

Instructions for use

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Precautions for Use

  • To avoid complications, it should not be closed in a contaminated wound without drainage.
  • When oxidized cellulose is used in proximity to nerve structure in areas of bony confinement (e.g., foramina, spinal cord, optic chiasma), it may lead to nerve damage.
  • The use of oxidized cellulose-based topical haemostats is not indicated to control biliary, urinary, pancreatic, and air leakages.

Storage

  • storage temperature: 15 - 30°C
  • Protect from sunlight ‐ Protect from humidity

MSF requirements

To be used in head trauma as an adjunct to ligation or other conventional methods to control capillary, venous, and small arterial haemorrhage.

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