The prosthesis intended for chest wall defects reconstructions used after the treatment of primary and metastatic cancers
Codubix® Ribs rib prosthesis is intended for reconstruction of extensive defects of chest wall.
Codubix® Ribs implant are manufactured with the use of knitting technique out of:
product code | length (mm) | width (mm) | unit package | shipping unit |
MA-272-KOZE-002 | 250 | 200 | 1 pc | 5 pcs |
Knitted polyester and polypropylene Codubix® Ribs grafts are intended for reconstruction of chest wall defects after the treatment of primary and metastatic cancers of chest wall and the non-small cell lung cancers infiltrating that structure.
Before using Codubix® Ribs prosthesis the following has to be exactly determined:
Final choosing and adjustment of the graft takes place during the surgical procedure (the implant can be cut).
Codubix® Ribs implant are delivered non-sterile. The sterilisation process has to be carried out in a validated moist heat sterilisation process in an autoclave:
The personnel involved in the steam sterilisation process has to possess appropriate qualifications for carrying out the steam sterilisation process (in accordance with the requirements of (PN-EN ISO 17665-1) .
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.
Bacterial endotoxin content in the lot is much below the requirements - the requirement being 20EU/device (in acc. with USP monoghaph 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.
Codubix® Ribs grafts fulfil all the requirements specified in PN-EN ISO 10993-1 norm and they also possess a number of documented biological tests.
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 is much below 0,3. Reference - clear water is characterised by the absorbance between 0,5 ÷ 2.
The Codubix® Ribs implant is packed in polyethylene bag on which TAG label is placed (identifying the device). The implant can be seen through the package.
The product packed in bag with IFU and additional double TAG label included is placed in a cardboard box. Such package ensures safe storage within the guaranteed validity period.
Codubix® Ribs rib prosthesis is intended for reconstruction of extensive defects of chest wall.
Codubix® Ribs implant are manufactured with the use of knitting technique out of:
product code | length (mm) | width (mm) | unit package | shipping unit |
MA-272-KOZE-002 | 250 | 200 | 1 pc | 5 pcs |
Knitted polyester and polypropylene Codubix® Ribs grafts are intended for reconstruction of chest wall defects after the treatment of primary and metastatic cancers of chest wall and the non-small cell lung cancers infiltrating that structure.
Before using Codubix® Ribs prosthesis the following has to be exactly determined:
Final choosing and adjustment of the graft takes place during the surgical procedure (the implant can be cut).
Codubix® Ribs implant are delivered non-sterile. The sterilisation process has to be carried out in a validated moist heat sterilisation process in an autoclave:
The personnel involved in the steam sterilisation process has to possess appropriate qualifications for carrying out the steam sterilisation process (in accordance with the requirements of (PN-EN ISO 17665-1) .
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.
Bacterial endotoxin content in the lot is much below the requirements - the requirement being 20EU/device (in acc. with USP monoghaph 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.
Codubix® Ribs grafts fulfil all the requirements specified in PN-EN ISO 10993-1 norm and they also possess a number of documented biological tests.
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 is much below 0,3. Reference - clear water is characterised by the absorbance between 0,5 ÷ 2.
The Codubix® Ribs implant is packed in polyethylene bag on which TAG label is placed (identifying the device). The implant can be seen through the package.
The product packed in bag with IFU and additional double TAG label included is placed in a cardboard box. Such package ensures safe storage within the guaranteed validity period.
Name | Size | Type |
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Product photos: Codubix® Ribs | 402.2 kB |
Name | Rozmiar | Type |
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Product photos: Codubix® Ribs | 402.2 kB |
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