Eu Mdd Eu Md Class 2b On The Market 🇹🇷 Türkiye

OcuVisc 1.0 % 1.6 mL Sodium Hyaluronate

Atakan DEDE - Miray Medikal · 🇹🇷 Türkiye
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
D-8699211169952E6
Basic UDI-DI Code
B-8699211169952E6
Reference
MRY-C65
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

OcuVisc is a clear, colorless, odorless, sterile, and isotonic viscoelastic solution for intraocular use. OcuVisc is steam-sterilized under pressure in its sterile packaging. The cannula is sterilized using ethylene oxide. Thanks to its special viscoelastic properties, OcuVisc maintains a deep anterior chamber and protects the corneal endothelium throughout the surgical operation. The viscoelastic properties of the preparation allow tissue structures to be moved without causing trauma, for example in cases of prolapse of the iris. Diagnostic and therapeutic procedures may be carried out in the eye without any impairment of vision. OcuVisc protects the intraocular tissue throughout surgery and prevents adhesion and synechia formation when performing ocular surgery. Once the surgery is finished, OcuVisc must be removed completely by irrigation and/or aspiration. Any residue that has not been removed from the anterior chamber will be flushed out naturally via the trabecular system and Schlemm’s canal. If it is not completely removed, intraocular pressure may increase due to obstruction of the trabecular system.

CND Nomenclature Codes

Code Description
Q02030301 OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES
Q02030399 OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER

Certificates

Type Number
MDD Annex II Section 4 2195-MED-1207901

Available In Countries

🇫🇷 France 🇹🇷 Türkiye

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