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OSSEOUS Gelatin Sponge Gyanec

EON MEDITECH PRIVATE LIMITED · Model E91078025 · UDI-DI 08906039313178

LAY Prescription
0
510(k) clearances
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Adverse events
0
Recalls
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Facilities

Description

"Absorbable Haemostatic Gelatin Sponge is a sterile malleable, water-insoluble, Gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface. Absorbable Haemostatic Gelatin Sponge is non-pyrogenic and biocompatible. Absorbable Haemostatic Gelatin Sponge is a surgical haemostatic sponge, manufactured from highly purified first grade gelatin material for use in various surgical procedures. When implanted in vivo and used in appropriate amounts, it is completely absorbed within 3-4 weeks. When applied to bleeding mucosal regions, it liquefies within 2 to 5 days. Absorbable Haemostatic Gelatin Sponge have a porous structure which activates the thrombocytes at the moment blood comes in contact with the matrix of the sponge. This causes the thrombocytes to release a series of substances which promote their aggregation at the same time as their surfaces change character, thus enabling them to act as a catalyst for the formation of the fibrin. "

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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.