Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 276

configuration codes. Figure 11.16 illustrates a typical bar code label for a Class II
nonsterile product. It has three main bar codes. The first is the manufacturing (packing)
date - the number in brackets is the universally recognized code (called a UCC identifier)
for this item of information. The second bar code is the batch/lot number (10), and the third
is the part number (code 241). As per normal, your PDS will have identified which bar code
style to use.
I do not know why, but it seems to be standard to affix the bar code on the back of the box
in the exact middle. However, I find this to be a silly idea; if your device is fragile you are
introducing a potential breakage just for identification purposes. Put the bar code label where
it is easy to get at (how many times have you been at a checkout watching the store staff
struggle to find the bar code for your purchase), and where its use will not cause damage.
11.3.4 Security Labels
Your packages should be made tamperproof. Hence it is a good idea to produce a standard
label that states:
Do not use if packaging damaged.
Use this as your final seal for the box/pack.
If your device is supplied sterile this label/statement (or wording like it) is mandatory.
11.3.5 Crossover of Symbols between USA and EC
Although standard symbols are commonplace in the EC, the same cannot be said for the
USA. EC companies selling in the USA have two choices: produce USA packaging and
labels, or (for small numbers) get a “meaning of symbols” label agreed to by the FDA
examiner. For USA companies there is no alternative but to use the agreed symbols in the
(11) 20120123
(10) 1-202001
(241) 1-10-0
Figure 11.16
Sample bar code label (UCC/EAN 128).