definiens: means penetrating the endothelial and ep ithelial barrier, whether by ( i ) incision ; ( ii ) inj ection ; or ( iii ) through use of a medical device ; and in each case of ( i ), ( ii ) and ( iii ), to deliver the Substan ce to reach the internal body cavity, tissue and/or organs . For the avoidance of doubt, does not include : ( A ) non - sterile device oral care products in liquid or gel formulat ion using the Oculus Method of Manufacturing and ha ving [ ] * with greater than [ ] * % degradation in [ ] * concent ration over a [ ] * ( [ ] * ) month shelf life pursuant to product release studies, ( B ) sterile or non - sterile product s for use with endotrachial tube disorders using th e Oculus Method of Manufacturing and having [ ] * with greater than [ ] * % degradation in [ ] * concentration over a [ ] * ( [ ] * ) month shelf life pursuant to product release studies, ( C ) non - sterile device products targeted for use with vacuum assisted closure products using the Oculus Method of Manufac turing and having [ ] * with greater than [ ] * % degr adation in [ ] * concentration over a [ ] * ( [ ] * ) month shel f life pursuant to product release studies ; ( D ) ste rile or non - sterile device products for cleaning catheters using the Oc ulus Method of Manufacturing and having [ ] * with g reater than [ ] * % degradation in [ ] * concentration over a [ ] * ( [ ] * ) month shelf life pursuant to product re lease studies, ( E ) Urinary Tract Infection Products, ( F ) non - steri le wound care products using the Oculus Method of Manufacturing and having [ ] * with greater than [ ] * % degradation in [ ] * concentration over a [ ] * ( [ ] * ) month shelf life pursuant to product release studies in t he United States, ( G ) sterile wound care products u sing the Oculus Method of Manufacturing and having [ ] * with greate r than [ ] * % degradation in [ ] * concentration over a [ ] * ( [ ] * ) month shelf life pursuant to product release st udies in the European Union, and ( H ) any services e mploying any of the products described in ( A ) – ( G ) of this section