RS-OIL ECS 5700 EASY CONNECTION SYRINGE

HIGH PURITY STERILE SILICONE OIL 5700 cSt, 10 ML IN SYRINGE WITH ADAPTER

SILICONE OIL
RS-OIL ECS 5700 RS-OIL ECS is highly
purified silicone oil (100%
100% silicone oil, obtained from the mixture of long and
Ingredient pure polydimethylsiloxane),
short molecular chains (100% polydimethylsiloxane)
5700 cSt, 10 ml, sterile and
Viscosity (25°C) 5415 - 5985 cSt apyrogenic, packaged in pre-
Specific gravity (25°C) 0.967 - 0.975 filled syringe, intended for long-
Refractive index (25°C) 1.40 term replacement of the vitreous
humour extracted during
Acidity index ≤ 0.15 ml NaOH 0.01 N
vitreoretinal surgery. Product
Heavy metals ≤ 5 ppm warrants a stable tamponade
Phenolic compounds ≤ 0.20 (250 - 270 nm) over the time and reduced
Volatility (10g/24h/150°C) ≤ 0.10 %w/w incidence of complications. The
ready-to-use syringe is made
Bacterial endotoxins < 0.2 EU/ml
of inert, plastic and silicone oil
Non-cytotoxic according to ISO 10993-5, compatible material to increase
direct contact test performed on two cell lines: patient’s safety by reducing the
Cytotoxicity Test
- retinal pigment epithelial cells (ARPE-19) risk of breakage during handling
- mouse fibroblasts cells (BALB 3T3 clone A31)
or surgery.
Form sterile fluid
Volume 10 ml
chemically inert unbreakable syringe with adapter in medical
Packaging
pouch
Sterilization moist heat according to EN ISO 17665-1 Ref.: RSO 011-00
Storage temperature room temperature Contents:
Expiry date 36 months
 1 chemically inert
unbreakable syringe of
Intended use intraocular tamponade during vitreoretinal surgery
high purity sterile RS-OIL
Class medical device
ECS 5700 (100% high
GMDN code P 45125
purity, sterile silicone oil
CND code Q 02030202
5700 cSt, 10 ml)
MD registration number 971093/R
 1 plunger
Medical device class IIb
 3 labels for product
CE mark CE 0477
traceability
 1 package insert
GS1-128 barcode

Viale Austria, 14
35020 Ponte S.Nicolò (PD)
Italy

VAT IT 00063370282

Phone +39 049 8962074 / 64

Fax +39 049 8962071

www.alchimiasrl.com
info@alchimiasrl.com
MKT-163 rev. 6