COMPRESS, GAUZE, 10 cm, 12 plies, 17 threads, sterile
STD
SDRECOMP1S-
Valid Article
Account code:
60210
HS Code:
300590
Last Updated on:
07/11/2024, 17:58:06
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).
M0201020101 - Cotton gauzes, folded, without x-ray detectable thread, sterile
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
GAUZE COMPRESS, woven, sterile
Definition
A non-medicated, sterile dressing item in the form of a patch (also referred to as a sponge) made from woven material and primarily designed to absorb fluids for medical purposes. It is used in wound care, making up of dressings and for any procedure requiring a sterile compress.
Specifications
Quality standards
EN 14079, 2003, Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
Technical specifications
- Absorbent gauze, 100 % cotton
- 17 threads/cm²
- Weight: 23 g/m²
- Thickness: 12 plies
- Surgical folding with turned in edges (so that no free thread is apparent after folding or when the first outside fold is opened)
- Sterile, for single use
- Dimensions:
- Large
- Folded: 10 cm x 10 cm
- Unfolded: 30 cm (± 0,5 cm) X 40 cm (± 0,5 cm)
- Small
- Folded: 5 cm x 5 cm
- Unfolded: 20 cm (± 0,5 cm) X 20 cm (± 0,5 cm)
Packaging & Labelling
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.
- per 5 for the 10 cm compresses SDRECOMP1S-
- individually for the 5 cm compresses SDRECOMP5S-
Instructions for use
Compresses intended for sterile medical and surgical care.
It is better to use sterile compresses rather than non sterile compresses that are sterilized in the field. This is important for quality, hygiene, time and cost reasons.
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