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FUJIFILM

FUJIFILM CORPORATION · Model SB-604 · UDI-DI 04547410313338

FFY Prescription
2
510(k) clearances
10
Adverse events
0
Recalls
103
Facilities

Description

This product is a medical device that is attached to a FUJIFILM gastrointestinal endoscope in order to suck air in the body cavity as well as to feed water into the balloon. Do not use this product for any other purpose.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.