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Designed for multiple withdrawals while maintaining sterility
The applicant stated that CMS has previously made similar distinctions between device categories with anatomical indications when it created device category codes C1748 (Endoscope, single-use ( i.e., disposable), upper GI, imaging/illumination device (insertable)), effective July 1, 2020, and subsequently created both C1747 (Endoscope, single use ( i.e., disposable), urinary tract, imaging/illumination device (insertable)), effective January 1, 2023, and C1601 (Endoscope, single-use ( i.e., disposable), pulmonary, imaging/illumination device (insertable)), effective January 1, 2024
Future research should focus on large-scale, well-controlled randomized trials with standardized dosing protocols, clearly defined deficiency thresholds, and long-term follow-up to strengthen the evidence base and guide clinical practice
K., Jeong, Y
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