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CustoMed

KENPAX INTERNATIONAL LIMITED · Model 1 · UDI-DI 74895237104127

FXP
10
510(k) clearances
125
Adverse events
0
Recalls
285
Facilities

Description

Shoe cover A non-sterile device made of a non-conductive material intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.

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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.