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CATHETER URETERAL, sterile, s.u., CH5

https://unicat.msf.org/cat/product/18285
STD SCTDCATU5D-

Valid Article

Former Code(s): -X
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.
U0201 - Ureteral catheters without balloon
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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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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URETERAL CATHETER

Definition

A flexible tube designed for introduction into the ureters. It is a radiopaque tube with a straight tip configuration. It has a single lumen and graduated markings. The device is mostly used for ureter dilation, bypass of partial obstructions, upper urinary tract drainage/irrigation during surgery, stone removal, or for retrograde urography.

Specifications

Quality standards

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

Technical specifications

  • Single lumen catheter
  • PVC, polyurethane or silicone
  • Graduated, minimum every 5 cm
  • Straight tapered tip with central opening, bevelled distal end, with minimum 1 lateral eye
  • Proximal end: straight cut
  • Removable Luer-Lock adaptor for connecting to a syringe
  • Flexible guide
  • Radio-opaque
  • May be coated to reduce friction
  • Diameter: CH5, CH6, CH7
  • Length: ± 70 cm
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Catheter intended for surgical programmes in case of ureter trauma.

Caution

Not to be confused with urethral (urinary) catheter.

Storage

  • Store below 30°C
  • Protect from sunlight ‐ Protect from humidity
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