VOLIFIL

Primary DI

08809369093089

Basic UDI-DI Code

B-08809369093089

Reference

LL5P3

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

BNC KOREA, Inc.

This product consists of stabilized sodium hyaluronate generated by streptococcal bacteria and formulated to a concentration of 20 mg/mL, suspended in a physiological buffer. It is a transparent, viscous and sterile gel, supplied in a disposable pre-filled syringe. The syringe is equipped with a plunger, a plunger rod and a finger grip. It has one syringe and two needles in a blister pack. The product contains Lidocaine hydrochloride (3.0 mg/ 1mL) and the addition of lidocaine provides a pain relieving effect during treatment.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).