Galenaspon

Primary DI

08904085093075

Basic UDI-DI Code

B-08904085093075

Reference

GLES 1001

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

EUCARE PHARMACEUTICALS PRIVATE LIMITED

Sterile Haemostatic Absorbable Gelatin Sponge – IP/USP is a hemostatic absorbable medical device manufactured from highly purified neutral gelatin material of porcine origin. It is a white, light white or almost white water-insoluble, highly porous, pliable product intended for application to bleeding surfaces as a hemostat during surgical procedures when use of conventional bleeding control procedures are ineffective, difficult to apply or impractical. The uniform porosity of Sterile Haemostatic Absorbable Gelatin Sponge - USP/ IP enables the fluid volume to hold on the bleeding site and creates a physical pressure resulting in an accelerated hemostasis. It adheres well to the bleeding site and can absorb blood or body fluids not less than 35 times of its own weight and assists in achieving hemostasis in 3 to 6 minutes. Sterile Haemostatic Absorbable Gelatin Sponge – IP/USP is biocompatible as per applicable EN ISO 10993 standards. Sterile Haemostatic Absorbable Gelatin Sponge – IP/USP is manufactured in different physical formats and/or shapes to suit the needs of surgeons for application for an effective hemostasis in different types of surgeries.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).