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CardioWrap®

MAST BIOSURGERY USA INC. · Model 130 x 200 x 0.02mm · UDI-DI 08964050362049

OMH Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
3
Facilities

Description

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

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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.