1. The subject of the contract is the delivery of endoprostheses and orthopedic implants.
2. The subject of the order is described in detail in Annexes No. 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
Upper limb reconstructive implants1. The subject of the order is the supply of endoprostheses and orthopedic implants.- reconstructive implants of the upper limb
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Threads and Tapes of UHMWPE1. The subject of the order is the supply of endoprostheses and orthopedic implants.- Threads and tapes UHMWPE
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Head of the radial bone1. The subject of the contract is the supply of endoprostheses and orthopedic implants.- head of the radial bone
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Angle tiles1. The subject of the order is the delivery of endoprostheses and orthopedic implants.- angular plates.
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Canniulated Angle Tiles1. The subject of the contract is the delivery of endoprostheses and orthopedic implants.- cannulated angular plates
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Octal plate1. The subject of the contract is the delivery of endoprostheses and orthopedic implants.- eight plate.
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Lockable tiles and nails1. The subject of the order is the delivery of endoprostheses and orthopedic implants.- blocked plates and nails
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.
Revision knee joint endoprosthesis1. The subject of the order is the delivery of endoprostheses and orthopedic implants.- Knee inspection endoprosthesis.
2. The subject of the order is described in detail in Annex 1 to the SWZ.
3. The Contracting Authority in Annex 1 to the SWZ requires that the Contractor provide the manufacturer, the trade name and the number of the catalogue code offered by the Contractor of the object of the contract.
4. The offered subject of the order must be compliant and approved for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), directive of the European Union 93/42/EEC of 14 June 1993 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It must have Declarations of Conformity and CE Certificates.
5. The devices supplied must be sterile. If permitted in the component description, the supply of medical devices in non-sterile form is permitted. In this case, the Contractor is obliged to provide appropriate containers serving as their packaging during sterilization and storage.
6. A trade name, catalogue number, series and for products supplied as a sterile expiry date shall be provided on the unit packaging before which the product can be safely used.
7. The validity period of the delivered products must be at least 12 months from the date of delivery to the Ordering Party.