Codoloops®
Coloured marking bands intended for retracting and supporting organs preparated during a surgery
1. Description of the product:
Codoloops® coloured marking bands are intended for supporting organs prepared during a surgery. The device is manufactured with knitting technique from polyester yarn and is shaped into a band with outer edges rolled inside. The properties of the pattern reduce the fraying on cut edges
Codoloops® coloured marking bands are available in three widths: 2, 3, and 4 mm, and in four colours: white, yellow, red, and blue:
| colour | product code | relaxed length (mm) | unit package | shipping unit |
| blue | MA-274-CR2B-001 | 2 x 900 | 10 pcs | 5 pack. |
| red | MA-274-CR2R-001 | 2 x 900 | 10 pcs | 5 pack. |
| white | MA-274-CR2W-001 | 2 x 900 | 10 pcs | 5 pack. |
| yellow | MA-274-CR2Y-001 | 2 x 900 | 10 pcs | 5 pack. |
| blue | MA-274-CR3B-001 | 3 x 900 | 10 pcs | 5 pack. |
| red | MA-274-CR3R-001 | 3 x 900 | 10 pcs | 5 pack. |
| white | MA-274-CR3W-001 | 3 x 900 | 10 pcs | 5 pack. |
| yellow | MA-274-CR3Y-001 | 3 x 900 | 10 pcs | 5 pack. |
| blue | MA-274-CR4B-001 | 4 x 900 | 10 pcs | 5 pack. |
| red | MA-274-CR4R-001 | 4 x 900 | 10 pcs | 5 pack. |
| white | MA-274-CR4W-001 | 4 x 900 | 10 pcs | 5 pack. |
| yellow | MA-274-CR4Y-001 | 4 x 900 | 10 pcs | 5 pack. |
Product characteristics:
- does not cause inflammatory reaction,
- susceptible to bending,
- fixed longitudinal and transverse dimensions,
- high mechanical resistance,
- easy to store,
- high chemical purity.
Intended use:
Codoloops® coloured marking bands are intended for retracting and supporting:
- white – nerves,
- yellow – urinary ducts,
- red – arteries,
- blue – veins.
2. Sterilisation:
Codoloops® coloured marking bands are sterile by radiation sterilisation – ionising radiation (R) in a process validated in acc. with PN-EN ISO 11137-2.
3.Biological parameters:
Sterility of Codoloops® coloured marking bands is confirmed periodically with sterility tests. The sterilisation indicators placed on each package prove the product's undergoing the sterilisation process.
Bacterial endotoxin content in the lot is much below the requirements - the requirement being 20EU/device (in acc. with USP monoghaphy 161).
Endotoxin content is a very important parameter due to the fact that some part of dead bacteria (endotoxins) is pyrogenic. This is the reason why there is a limit on the content of dead bacteria in medical devices.
Microbiological purity determined in acc. with PN-EN ISO 11737-1; accepted limit: max. 100 microorganisms/1g of the device. Before the sterilisation process periodical tests of microbiological purity of random-chosen products are carried out; such procedure guarantees full safety of use of the product.
Codoloops® coloured marking bands fulfil all the requirements specified in PN-EN ISO 10993-1 norm and they also possess a number of documented biological tests.
4. Chemical parameters:
Permanganate oxidability – an important parameter of chemical purity. It shows the level of contamination, mainly organic, but also some non-organic, such as iron salts (II), sulphides or nitrates (III). The level of permanganate oxidability in serial devices is less than 0,08mg O2/g. Reference - clear water is characterised by the oxidability not exceeding 4mg O2/dm3.
UV absorbance at a given wavelength – this parameter proves the lack of, mainly organic, contamination. The maximum absorbance at a given wavelength for serial products does not exceed 0,3. Reference - clear water is characterised by the absorbance between 0,5 ÷ 2.
5. Physical parameters:
Breaking strength - dependently on the size: from min. 90 to min. 200 N - guarantees high breaking strength of the band.
6. Packaging:
Codoloops® coloured marking bands are packed in medical packages (fulfilling PN-EN ISO 11607 requirements) - paper-foil bags adequate for radiation sterilisation. On the outer packaging there is a TAG label (easy to peel-off, self-adhesive, identifying the device). The transparent package enables having a look into it and inspecting the device.
10 pieces (in one colour) of sterile bands packed in medical packages with the IFU included are placed in a cardboard box. Such package ensures safe storage within the guaranteed validity period.
| Name | Size | Type |
|---|---|---|
| Product photos: Codoloops® | 6.76 MB |
| Name | Rozmiar | Type |
|---|---|---|
| Product photos: Codoloops® | 6.76 MB |