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Eur. Ph. Injectable quality hyaluronic acid for Intraocular use, from biofermentation origin
Each box contains 1 syringe - 1 x 27G 7/8” canula - 1 leaflet -
8 traceability labels
Glass syringe, Pharmaceutical grade, Class I, latex free, prefilled At 1 ml
NaHa concentration 15,5 mg/g
Molecular weight of the hyaluronic acid in the final sterile product 2.2 MDa (mean value)
Phosphate Buffer pH 7,2 q.s. 1g
With natural antioxidant Hyaluronic acid with mannitol
Isoosmolarity 310 most (mean value)
pH 6.8 – 7.6
Viscosity at 0,01s-1 shear rate 170 Pa.s (170 000 cPoise) (mean value)
Apyrogen (free of endotoxins) < 0.5 EU/g
Sterile (gel by autoclave – second packaging, blister by ETO) SAL 10-6 (Sterility Assurance Level)
Proteins < 20 ppm
Storage 2°C to 25°C for up to 36 months
Medical Device Class IIb
Biocompatible according to ISO 10993 and ISO 15798
System of quality management in conformity to ISO 13485