Derma Veil is a lyophilized low viscosity, non-toxic, bioabsorbable and biodegradable tissue reconstructive material with the following characteristics:
– Disposable single use medical device incorporated as a hydrophilic matrix. Its active principle is composed of glycolic acid (GA) bound to the polymeric column of polylactic acid [PURASORB® Poly (L-lactide)] both of which are homogeneously dispersed throughout and their rate of release is controlled by diffusion, prolonging a sustained repairing action through the slow dissolution of the compound.
– Immunologically inactive, biocompatible and absorbable and is degraded by hydrolysis. The degradation begins first by water diffusion in the material, initially at the more amorphous zones, followed by hydrolysis, material fragmentation and finally, a more extensive hydrolysis along with phagocytosis, diffusion and metabolization. Elimination occurs primarily through the respiratory tract.
Each box of Derma Veil contains 2 vials and an Instruction for Use leaflet. The vials are made of transparent borosilicate glass, sealed with a siliconized halobutyl stopper secured by an aluminum ring with a “flip off” plastic cap.
The vial has 10 mL capacity and contains 236.14 mg of a lyophilized, sterile, pyrogen free, crystalline white powder of asymmetric micro-particles made of:
- – POLYLACTIC ACID a biocompatible, biodegradable synthetic polymer for medical applications, [PURASORB® Poly (L-lactide)]
- – GLYCOLIC ACID a biocompatible, biodegradable, high purity hydroxyacetic acid monomer for medical applications,
- – CARBOXY METHYL CELLULOSE SODIUM (USP),
- – MANNITOL (USP),
- – POLYSORBATE 80 (NF),
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