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Elite Custom Plus

AUGUSTA MEDICAL SYSTEMS, L.L.C. · Model External Penile Rigidity Device · UDI-DI 00852598007141

LKY
10
510(k) clearances
17
Adverse events
0
Recalls
48
Facilities

Description

External Penile Rigidity Device that contains kit bag, battery vacuum pump, constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.

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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.