SURGICAL VESSEL LOOP, 4 mm, 60 cm

STD SSUTSLOO4B6

Valid Article

Former Code(s): -X SSUTTASU4B6
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.
H900202 - Marking tapes, vascular structures
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The order of this product needs to be justified and is only acceptable under certain conditions.
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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SURGICAL VESSEL LOOP

Definition

A sterile, nonimplantable ribbon intended to be used during a surgical procedure to assist a surgeon to identify, retract and occlude blood vessels, tendons and nerves. It is constructed of synthetic polymer and is typically coloured to facilitate visualization.

Specifications

Quality Standards Comment

European Pharmacopoeia

Technical specifications

  • Synthetic: silicone, polyester, polypropylene, nylon ... (latex-free). cotton is not an interesting material as it absorbs liquids
  • Tubular (preferred) or braided
  • Non-absorbable
  • Width: 3 to 4 mm or 2 - 2.5 mm
  • Length: +/- 60 cm
  • No colour requirements
  • Sterile, for single use

Packaging & Labelling

Unit double sterile packaging

Box of 15 or 24 units, according to manufacturer

(Cf Introduction: Packaging and labelling)

Instructions for use

Suspensory tape only used during the surgical intervention to isolate vessels or nerves, and removed before closure of the operation wound.

Image

Storage

Below 30°C

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