Reusable surgical Instrument is under class IIa?

[Jen]

Hi. There are a few pieces of reusable surgical instruments from my supplier is listed under class IIa. I just don't understand why those reusable surgical instruments are not put in class I. Based on MDD classification rule 6, the reusable surgical instrument should be under class I.

I have tried to ask the reason for those instruments put under class IIa but the supplier just can't give me a clear answer.

Just wondering is there any reasons for reusable surgical instruments is be put under class IIa?

 

[monoj mon]

What is the intended purpose of those instruments!

 

[Jen]

There are two groups of instruments. Wire guides / Cerclage Instruments and extraction instrument. They share one general intended use.

The orthopedic or traumatology instrument is used in orthopedic or trauma surgery, e.g. for procedures involving implantations of endoprostheses or fracture implants.

 

[Jen]

Is that because the devices are used for endoprostheses and therefore under class iia?

 

[depa1978]

Hi, or in some cases it could that they are drilled (with an active device class IIa) and so they take this class..