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Barcode (UDI): 8698819447356
Catalog No: ORT-155=L
Product Type: Medical Device
Origin: Manufactured in Turkey
GMDN: External limb prosthesis socket shell fabrication material (64714)
Regulation: 2017/745
Description: A material intended to be used to manufacture a socket (shell) of an external upper or lower limb prosthesis which is designed to function as the limb-prosthesis interface. It consists of a mouldable piece/sheet of resin, thermoplast, duroplast, wood, silicone, fibreglass, aluminium, carbon fibre, or other suitable material; some types have non-pharmaceutical antimicrobial features for hygienic purposes. It is customized and shaped to a patient’s residual limb using a patient cast or computer-based anatomical imaging 3-D printing.