CATHETER URETERAL, sterile, s.u., CH6
STD
SCTDCATU6D-
Valid Article
Account code:
60210
HS Code:
901890
Last Updated on:
07/11/2024, 18:22:20
Former
Code(s):
-X
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).
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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
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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