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Oxidized Regenerated Cellulose Haemostat - India CDSCO Medical Device Registration

Oxidized Regenerated Cellulose Haemostat is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000726_aa06224a93603254ed27e23dc93903e5_35cac700df7a0c334ce1a0f9ca7b75f8. This device is marketed under the brand name SURGISPON, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHASPON. The license holder is M/s AKSHAR GAMMA STERILES LLP, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.

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Class Class D
Oxidized Regenerated Cellulose Haemostat
UID: MFG/MD/2022/000726_aa06224a93603254ed27e23dc93903e5_35cac700df7a0c334ce1a0f9ca7b75f8

Brand Name

SURGISPON, MEDISPONGE, UNISPONGE, BLOXANG, GEL-SPONGE, HEMOGEL, HEMOSPONGE, PERISPONGE™, SURGIGEL, TOP DENT DENTOSTAN, EVOSPON, CLINIX, HYGITECH, R&S, KENTDENTAL, OCTOCALOGEN, TOPISPON, SURGISENZ, MVG, SCHMIDT, ILION DENTAL, GELASPON, GELASPON KDM, PROCLINIC, BESTDENT, STELLIGEL, BIOSPONGE, FLOSPONG, SMI-SPON, MEDISPON, CLINISPON, I-SPONGE, MERIFEIM, DSI SPONGE, CHIRUSPONGE, MERIFOAM, IDSPONGE, DENTOSPON, KARESPON, HEMOSPON, ALPHASPON

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Oxidized Regenerated Cellulose Haemostat is used adjunctively in various surgical procedures to assist when control of bleeding from capillary, venous and small arteriolar vessels, by pressure, ligature and other conventional procedures is either ineffective or impractical. The Oxidized Regenerated Cellulose Haemostat can be cut to size in endoscopic procedures.

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