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FUJIFILM

FUJIFILM CORPORATION · Model BS-3 · UDI-DI 04547410463439

FDA Prescription

510(k) clearances

825

Adverse events (10 deaths)

Recalls

Facilities

Description

This product is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians. Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.