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While we did not question whether the ureteroscope itself is integral to the service furnished, we questioned whether the MEMS pressure sensor, the mechanism which the applicant asserts is the distinguishing feature of the LithoVue TM Elite Ureteroscope, is integral to the service furnished in accordance with 419.66(b)(3), because pressure monitoring during ureteroscopy procedures appears to be purely additive and not necessary to furnish the ureteroscopy

The FDA classifies it as a Category 2 bulk drug substance, noting potential safety concerns in unregulated compounding

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B12 Intramuscular Dose Frequency How often B12 injections are given changes over time

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