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/2019/000187_aa06224a93603254ed27e23dc93903e5_f443107266cfe98e206991335914f142. This device is marketed under the brand name Surgi-ORC, HEMOCEL, ORCEL, PREMISUT, ORCBOND. The license holder is Aegis Lifesciences Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Oxidized Regenerated Cellulose Haemostat

UID: MFG/MD/2019/000187_aa06224a93603254ed27e23dc93903e5_f443107266cfe98e206991335914f142

Brand Name

Surgi-ORC, HEMOCEL, ORCEL, PREMISUT, ORCBOND

License Holder

Aegis Lifesciences Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Oxidized Regenerated Cellulose Haemostat is designed to arrest capillary bleeding and bleeding from parenchymatous organs and resection areas at surgical interventions. It is suitable for use in general surgery and digestive surgery, neurosurgery (Surgi-ORC, HEMOCEL, ORCEL, PREMISUT, ORCBOND), plastic surgery, orthopaedic, gynaecology, urology, stomatology, traumatology, and many other branches of surgery. Oxidized Regenerated Cellulose Haemostat can be applied into cavities (Surgi-ORC, HEMOCEL, ORCEL, PREMISUT, ORCBOND) as well as endoscopic interventions or dental praxis. 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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Oxidized Regenerated Cellulose Haemostat

Brand: 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

M/s AKSHAR GAMMA STERILES LLP

Class D

Oxidized Regenerated Cellulose Haemostat

Brand: SURGISPON, GELBOND, HEMALIMIT, NEXCARE, PREMISUT, SURGIVET

M/s. Universal ISO-MED (A Div. of Universal Medicap Ltd.)

Class D

Oxidized Regenerated Cellulose Haemostat

Brand: FLOGEL

M/s Universal Medicap Ltd.

Class D

Oxidized Regenerated Cellulose Haemostat

Brand: 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, ALPHA-SPON

M/s ELECTRO MAGNETIC INDUSTRIES

Class D