FDA Device Intelligence
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PremierPro

PRESTIGE AMERITECH, LTD. · Model 3640 · UDI-DI 00818566017635

EYQ
10
510(k) clearances
201
Adverse events (2 deaths)
0
Recalls
421
Facilities

Description

Mesh Pants, Disposable, Medium, Blue, 25/bg, 4bgs/case

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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.