D
dwayneq
Forgive me if this has been covered already. I did some searching but didn't see an appropriate answer. We have a class II plastic kit assembly this is minimally invasive. Currently we have the following items covered: company name, product description, catalog number, quantity included, manufacturing company address, lot identification, manufacture date, expiration date, use requires prescription, protect from liquids, latex free, xxx, xxx, sterile by EO, see user manual, label part number, and UDI barcode.
On durable equipment and electromechanical parts used on durable equipment we also list operating conditions as well as storage and shipping conditions. I don't believe that this information is required on these sterile sealed plastic components but I have been questioned on this. I have not found anything so far that points me one way or another. Can anyone point me to label requirements that would help clear this up?
Thank you, Dwayne
On durable equipment and electromechanical parts used on durable equipment we also list operating conditions as well as storage and shipping conditions. I don't believe that this information is required on these sterile sealed plastic components but I have been questioned on this. I have not found anything so far that points me one way or another. Can anyone point me to label requirements that would help clear this up?
Thank you, Dwayne