Polysulfone (PSU): Eviva®
Product | Availability | Product Description |
---|---|---|
Eviva® EV-25000 | Asia Pacific |
Eviva® EV-25000 and EV-26000 are grades of polysulfone (PSU) offered exclusively for use in implantable portacaths (central venous access devices). Eviva® EV-25000 is the neat version of the polymer and Eviva® EV-26000 is an opaque white grade.
The manufacturing facility for Eviva® PSU in Alpharetta, GA is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied.
Our biomaterials manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in a lab that is ISO 17025 accredited.
An FDA MAF is available. In Japan, a PMDA MF is available.
|
Eviva® EV-26000 | Asia Pacific |
Eviva® EV-25000 and EV-26000 are grades of polysulfone (PSU) offered exclusively for use in implantable portacaths (central venous access devices). Eviva® EV-25000 is the neat version of the polymer and Eviva® EV-26000 is an opaque white grade.
The manufacturing facility for Eviva® PSU in Alpharetta, GA is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied.
Our biomaterials manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in a lab that is ISO 17025 accredited.
An FDA MAF is available. In Japan, a PMDA MF is available.
|
Eviva® EV-500 | Asia Pacific |
Eviva® EV-500 polysulfone (PSU) is offered for use in implantable medical devices. Eviva® EV-500 is the neat version of the polymer and Eviva® EV-501 is an opaque white grade.
The manufacturing facility for Eviva® PSU in Alpharetta, GA is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. Our biomaterial manufacturing processes are carefully validated, and enhanced controls provide product traceability. In addition, all materials are tested in a lab that is ISO 17025 accredited.
An FDA MAF is available.
|
Eviva® EV-501 | Asia Pacific |
Eviva® EV-501 polysulfone (PSU) is offered for use in implantable medical devices. Eviva® EV-500 is the neat version of the polymer and Eviva® EV-501 is an opaque white grade.
The manufacturing facility for Eviva® PSU in Alpharetta, GA is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied.
Our biomaterials manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in a lab that is ISO 17025 accredited.
An FDA MAF is available.
|