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1.3 Supplier: BIONIX RESEARCH Email: [email protected] 1.4 Emergency: EU Emergency Number: 112 SECTION 2 Hazards Identification 2.1 Classification: Not classified as hazardous under CLP Regulation (EC) 1272/2008

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Per the applicant, the existing pass-through code C1747 (Endoscope, single-use ( i.e., disposable), urinary tract, imaging/illumination device (insertable)) does not appropriately describe the LithoVue TM Elite Ureteroscope because the category description does not include the LithoVue TM Elite Ureteroscope's pressure monitoring feature

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Q27: Is 5-Amino-1MQ FDA approved

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We note that we solicited comments on payment policies for software as a service in the CY 2026 OPPS/ASC proposed rule and refer readers to section III.F

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