CrISTAVISC® C Viscoelastic
Viscoelastic materials used in surgeries are generally employed to protect tissues, increase lubrication, and support wound healing during surgical procedures.
Ophthalmic Surgery: Viscoelastic is frequently used in ophthalmic surgery. During intraocular surgery, it creates volume in the anterior chamber of the eye, protecting the eye structure and expanding the surgeon’s working space. These types of viscoelastics are used in cataract surgeries and other eye surgeries.
CrISTAVISC® C Viscoelastic
| DESIGNATION | TECHNICAL SPECIFICATIONS |
|---|---|
| Eur. Ph. compliant, quality hyaluronic acid for intraocular use that is injectable and biofermentation in origin | — |
| Each box contains | 1 syringe – 1 x 27G 7/8” canula – 1 leaflet – 10 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 mOsm (mean value) |
| pH | 6.8 – 7.6 |
| Viscosity at 0,01s-1 shear rate | |
| Apyrogen (no endotoxins) | < 0.5 EU/g |
| Sterile (gel by autoclave – second packaging with blister, sterilization with ethylene oxide) | 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 Quality Management System certified | ISO 10993 and ISO 15798 ISO 13485 |
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