About Project:

F-SYSTEM

Field of Application

The Powder-Liquid Mixing System is designed to STORE, ACTIVATE and DELIVER prefilled calcium phosphate bone cements, pastes or gels. The proprietary MEDMIX valve technology allows two components to be transferred, mixed and delivered cleanly and easily with a minimal risk of failure. An optional dispensing gun is available for highly viscous materials in combination with thin cannulas.

Features and benefits

Standard interfaces for hydration and enrichmentStandard Luer interface to connect to standard Luer needles and cannulas or for biomaterial enrichment from vials.
All-in-one deviceCompact and closed device for safe and clean application. The MEDMIX cannula portfolio is fully compatible with the syringes and offers precise access to the point of surgery.
Full biocompatibilityPremium medical grade resins compliant with USP VI requirements. All products are manufactured and packed under controlled ISO 8 cleanroom (comparable to U.S. Class M 6.5 or Class 100,000).
Support for your approval procedure included in our service MEDMIX products undergo full process validation and we support your approval process with adequate documentation and information.

Specifications

Available sizes:                    4ml liquid capacity / 10ml mixed material

Interfaces:                            Male Luer

Sterilization:                         Gamma / ETO

Production environment:      ISO 8

Material grade:                     USP VI