 - Kopi-1200x1200.jpg "Cristalens Cristavisc")
Varenummer: Cristavisc
| DESIGNATION | TECHNICAL SPECIFICATIONS |
|---|---|
| Eur. Ph. Injectable quality hyaluronic acid for Intraocular use, from biofermentation origin |
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| Each box contains | 1 syringe - 1 x 27G7/8” canula - 1 leaflet - 8 traçeability 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 | Mannitol |
| Isoosmolarity | 280-360 mOsm |
| 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- 25°C during 36 months, room temperature |
| Medical Device | Class IIb |
| Medical Device | Class IIb |
| Biocompatible according to | ISO EN 10993 and ISO EN 15798 |
| System of quality management in conformity to | ISO13485 |