ParisTommy
Starting to get Involved
Hello,
I am getting into a bit of trouble defining if I have a system on my hands or not.
I have a handle and an invasive wire, both sterile, single use, intended to be used exclusively together, placed on the market together in a single box, but packaged and sterilised seperately.
The wire needs the handle to be used, the handle needs the wire to be used, they can't be used seperately, or in any other configuration.
Can I place it on the market with 1 UDI-DI & 1 UDI-PI on the outer box (sales unit), with the lot N° and the shortest expiry date (either the wire or handle) ?
I will assign 1 Basic UDI and 1 UDI-DI
The wire and the handle won't have UDI-DI, and so therefore, won't have a datamatix, they will just be labeled as per the requirements for the sterile barrier MDR Annex II §23.3, (expiry date, manufacture date description etc...)
Kind regards
Thomas
I am getting into a bit of trouble defining if I have a system on my hands or not.
I have a handle and an invasive wire, both sterile, single use, intended to be used exclusively together, placed on the market together in a single box, but packaged and sterilised seperately.
The wire needs the handle to be used, the handle needs the wire to be used, they can't be used seperately, or in any other configuration.
Can I place it on the market with 1 UDI-DI & 1 UDI-PI on the outer box (sales unit), with the lot N° and the shortest expiry date (either the wire or handle) ?
I will assign 1 Basic UDI and 1 UDI-DI
The wire and the handle won't have UDI-DI, and so therefore, won't have a datamatix, they will just be labeled as per the requirements for the sterile barrier MDR Annex II §23.3, (expiry date, manufacture date description etc...)
Kind regards
Thomas
