CRISTALENS / VISCOELASTICS

CRISTAVISC® C

Eur. Ph. Injectable quality hyaluronic acid for Intraocular use, from biofermentation origin

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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)

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

Important notice: The information presented in this section is intended exclusively for healthcare professionals and specialists. It does not constitute medical advice to the public and does not replace clinical judgment. For proper use, please refer to the official documentation and the manufacturer's instructions.

TECHNICAL CHARACTERISTICS